Trial Outcomes & Findings for Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT) (NCT NCT03945292)
NCT ID: NCT03945292
Last Updated: 2025-11-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Baseline, Week 16 (+/- 2 weeks)
Results posted on
2025-11-04
Participant Flow
Randomization was performed within each dose cohort to maintain blinding due to different dose volumes in the double-blinded phase.
Participant milestones
| Measure |
Fazirsiran 200 mg DB/200 mg OL
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 200 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Fazirsiran 25 mg
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 25 mg DB/200 mg OL
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 25 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Fazirsiran 100 mg DB/200 mg OL
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 100 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Placebo DB / Fazirsiran 200 mg OL
Participants with fibrosis at Screening who received double-blind (DB) placebo and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Double-Blind (DB) Period: Weeks 0 to 48
STARTED
|
0
|
9
|
8
|
9
|
14
|
0
|
0
|
0
|
|
Double-Blind (DB) Period: Weeks 0 to 48
COMPLETED
|
0
|
8
|
8
|
7
|
14
|
0
|
0
|
0
|
|
Double-Blind (DB) Period: Weeks 0 to 48
NOT COMPLETED
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Open-Label (OL) Period: Weeks 48 to 196
STARTED
|
5
|
0
|
0
|
0
|
0
|
4
|
5
|
9
|
|
Open-Label (OL) Period: Weeks 48 to 196
COMPLETED
|
5
|
0
|
0
|
0
|
0
|
4
|
5
|
8
|
|
Open-Label (OL) Period: Weeks 48 to 196
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Fazirsiran 200 mg DB/200 mg OL
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 200 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Fazirsiran 25 mg
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 25 mg DB/200 mg OL
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 25 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Fazirsiran 100 mg DB/200 mg OL
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 100 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Placebo DB / Fazirsiran 200 mg OL
Participants with fibrosis at Screening who received double-blind (DB) placebo and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Double-Blind (DB) Period: Weeks 0 to 48
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Period: Weeks 0 to 48
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open-Label (OL) Period: Weeks 48 to 196
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)
Baseline characteristics by cohort
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 15.56 • n=15 Participants
|
47.9 years
STANDARD_DEVIATION 12.25 • n=161 Participants
|
51.6 years
STANDARD_DEVIATION 9.44 • n=100 Participants
|
57.4 years
STANDARD_DEVIATION 9.05 • n=3 Participants
|
53.1 years
STANDARD_DEVIATION 12.33 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=15 Participants
|
6 Participants
n=161 Participants
|
6 Participants
n=100 Participants
|
5 Participants
n=3 Participants
|
22 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
9 Participants
n=3 Participants
|
18 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=15 Participants
|
7 Participants
n=161 Participants
|
9 Participants
n=100 Participants
|
12 Participants
n=3 Participants
|
37 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=15 Participants
|
8 Participants
n=161 Participants
|
9 Participants
n=100 Participants
|
14 Participants
n=3 Participants
|
40 Participants
n=8 Participants
|
|
Fibrosis Status at Screening
Fibrosis at Screening
|
4 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
7 Participants
n=100 Participants
|
9 Participants
n=3 Participants
|
25 Participants
n=8 Participants
|
|
Fibrosis Status at Screening
No fibrosis at Screening
|
5 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
5 Participants
n=3 Participants
|
15 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16 (+/- 2 weeks)Population: Full Analysis Set: All randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Z-Alpha-1 Antitrypsin (Z-AAT) at Week 16
|
-62.17 percentage change
Standard Error 4.279
|
-85.39 percentage change
Standard Error 4.634
|
-92.93 percentage change
Standard Error 4.341
|
4.64 percentage change
Standard Error 3.211
|
—
|
—
|
SECONDARY outcome
Timeframe: Double Blind Phase (up to Week 48): dose administration through end of study (EOS) or Early Termination or first dose of open-label phase fazirsiran.Population: Safety Analysis Set: All participants who receive at least one dose of study drug.
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction. TEAEs/TESAEs are defined as those AEs that first occurred or worsened in severity following dose administration through end of study (EOS) or Early Termination or first dose of open-label phase fazirsiran.
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TESAEs
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAEs Leading to Withdrawal of Study Drug
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAEs Leading to Study Termination
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAEs by Worst Severity: Moderate
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAEs by Worst Severity: Severe
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAEs by Worst Relationship: Not Related
|
7 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAEs by Worst Relationship: Possibly Related
|
2 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAEs by Worst Relationship: Possibly or Probably
|
2 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAE at Injection Site
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAEs
|
9 Participants
|
8 Participants
|
9 Participants
|
14 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAEs by Worst Severity: Mild
|
3 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase
TEAEs by Worst Relationship: Probably Related
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From dose administration of the first dose of open-label phase fazirsiran through EOS or Early Termination (up to Week 196).Population: Safety Analysis Set: All participants who receive at least one dose of study drug.
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction. TEAEs/TESAEs are defined as those AEs that first occurred or worsened in severity following dose administration through end of study (EOS) or Early Termination or first dose of open-label phase fazirsiran.
Outcome measures
| Measure |
Fazirsiran 25 mg
n=4 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=5 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=5 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=9 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAEs
|
4 Participants
|
4 Participants
|
3 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TESAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAEs Leading to Withdrawal of Study Drug
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAEs Leading to Study Termination
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAEs by Worst Severity: Moderate
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAEs by Worst Relationship: Probably Related
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAEs by Worst Relationship: Possibly or Probably
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAE at Injection Site
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAEs by Worst Severity: Mild
|
3 Participants
|
2 Participants
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAEs by Worst Severity: Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAEs by Worst Relationship: Not Related
|
2 Participants
|
0 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase
TEAEs by Worst Relationship: Possibly Related
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)Population: Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.
Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.
Outcome measures
| Measure |
Fazirsiran 25 mg
n=4 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=5 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=7 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=8 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Total Liver Z-AAT (Insoluble + Soluble) Protein at Post-dose Biopsy for Participants With Fibrosis
|
-89.341 nmol/g
Standard Deviation 94.832
|
-259.892 nmol/g
Standard Deviation 330.199
|
-29.371 nmol/g
Standard Deviation 22.867
|
-4.738 nmol/g
Standard Deviation 57.342
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)Population: Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.
Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.
Outcome measures
| Measure |
Fazirsiran 25 mg
n=4 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=5 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=7 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=8 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Liver Z-AAT (Insoluble + Soluble) Protein at Post-dose Biopsy for Participants With Fibrosis
|
-86.89 percentage change
Standard Error 29.658
|
-81.61 percentage change
Standard Error 29.503
|
-98.16 percentage change
Standard Error 23.256
|
42.42 percentage change
Standard Error 21.133
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)Population: Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.
Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.
Outcome measures
| Measure |
Fazirsiran 25 mg
n=4 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=5 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=7 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=8 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Liver Z-AAT Soluble Protein at Post-dose Biopsy for Participants With Fibrosis
|
-20.427 nmol/g
Standard Deviation 15.042
|
-109.747 nmol/g
Standard Deviation 135.114
|
-17.418 nmol/g
Standard Deviation 4.860
|
2.300 nmol/g
Standard Deviation 12.940
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)Population: Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.
Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.
Outcome measures
| Measure |
Fazirsiran 25 mg
n=4 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=5 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=7 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=8 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Z-AAT Soluble Protein at Post-dose Biopsy for Participants With Fibrosis
|
-75.73 percentage change
Standard Error 16.645
|
-87.23 percentage change
Standard Error 17.064
|
-95.71 percentage change
Standard Error 12.824
|
22.33 percentage change
Standard Error 11.890
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)Population: Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.
Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.
Outcome measures
| Measure |
Fazirsiran 25 mg
n=4 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=5 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=7 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=8 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Liver Z-AAT Insoluble Protein at Post-dose Biopsy for Participants With Fibrosis
|
-68.914 nmol/g
Standard Deviation 80.725
|
-150.145 nmol/g
Standard Deviation 196.675
|
-11.953 nmol/g
Standard Deviation 18.602
|
-7.038 nmol/g
Standard Deviation 47.041
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)Population: Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.
Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.
Outcome measures
| Measure |
Fazirsiran 25 mg
n=4 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=5 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=7 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=8 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Z-AAT Insoluble Protein at Post-dose Biopsy for Participants With Fibrosis
|
-86.36 percentage change
Standard Error 60.305
|
-72.44 percentage change
Standard Error 58.358
|
-101.85 percentage change
Standard Error 47.495
|
91.35 percentage change
Standard Error 42.750
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 28
|
-10.7 U/L
Standard Deviation 4.57
|
-5.8 U/L
Standard Deviation 9.56
|
0.6 U/L
Standard Deviation 6.48
|
1.0 U/L
Standard Deviation 6.91
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 40
|
-4.6 U/L
Standard Deviation 9.07
|
-5.0 U/L
Standard Deviation 8.78
|
3.1 U/L
Standard Deviation 9.79
|
-0.1 U/L
Standard Deviation 4.66
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 100
|
-9.0 U/L
Standard Deviation 2.83
|
-21.5 U/L
Standard Deviation 9.19
|
7.5 U/L
Standard Deviation 7.78
|
1.3 U/L
Standard Deviation 9.43
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 112
|
-8.0 U/L
Standard Deviation NA
1 participant analyzed
|
-18.0 U/L
Standard Deviation 7.07
|
8.0 U/L
Standard Deviation 4.24
|
-0.3 U/L
Standard Deviation 6.43
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 124
|
—
|
-18.0 U/L
Standard Deviation 4.24
|
7.0 U/L
Standard Deviation NA
1 participant analyzed
|
5.0 U/L
Standard Deviation 11.53
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 160
|
—
|
—
|
—
|
23.0 U/L
Standard Deviation 4.24
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Early Termination
|
—
|
—
|
-2.0 U/L
Standard Deviation 9.90
|
—
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
End of Study
|
7.0 U/L
Standard Deviation 16.64
|
-1.0 U/L
Standard Deviation 5.66
|
-0.5 U/L
Standard Deviation 4.95
|
-0.2 U/L
Standard Deviation 5.45
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
PDLB at Week 48
|
-10.5 U/L
Standard Deviation 10.47
|
0.0 U/L
Standard Deviation 16.00
|
-2.2 U/L
Standard Deviation 5.31
|
3.3 U/L
Standard Deviation 7.71
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 52
|
-1.5 U/L
Standard Deviation 12.31
|
-6.0 U/L
Standard Deviation 7.39
|
12.3 U/L
Standard Deviation 33.80
|
-0.4 U/L
Standard Deviation 4.44
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 64
|
-9.8 U/L
Standard Deviation 8.50
|
-14.3 U/L
Standard Deviation 8.88
|
-0.3 U/L
Standard Deviation 8.30
|
5.7 U/L
Standard Deviation 15.48
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
PDLB at Week 72
|
—
|
—
|
—
|
-6.0 U/L
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 76
|
-7.3 U/L
Standard Deviation 3.06
|
-14.8 U/L
Standard Deviation 9.07
|
3.5 U/L
Standard Deviation 8.24
|
7.7 U/L
Standard Deviation 8.85
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 88
|
-9.0 U/L
Standard Deviation 3.46
|
-18.5 U/L
Standard Deviation 9.19
|
4.8 U/L
Standard Deviation 4.97
|
6.2 U/L
Standard Deviation 7.76
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
PDLB at Week 96
|
—
|
-21.0 U/L
Standard Deviation 5.66
|
12.0 U/L
Standard Deviation NA
1 participant analyzed
|
10.0 U/L
Standard Deviation 12.73
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 136
|
—
|
—
|
4.0 U/L
Standard Deviation NA
1 participant analyzed
|
8.3 U/L
Standard Deviation 17.90
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 148
|
—
|
—
|
11.0 U/L
Standard Deviation NA
1 participant analyzed
|
4.3 U/L
Standard Deviation 14.98
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 16 + 24 H
|
-7.3 U/L
Standard Deviation 11.93
|
-3.8 U/L
Standard Deviation 3.59
|
-2.2 U/L
Standard Deviation 2.86
|
0.8 U/L
Standard Deviation 5.31
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)
Week 16
|
-3.0 U/L
Standard Deviation 9.17
|
-2.4 U/L
Standard Deviation 5.42
|
-8.4 U/L
Standard Deviation 15.88
|
1.7 U/L
Standard Deviation 6.60
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 16
|
-9.6 percentage change
Standard Deviation 20.1
|
-4.3 percentage change
Standard Deviation 19.9
|
-15.3 percentage change
Standard Deviation 16.2
|
5.8 percentage change
Standard Deviation 16.1
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 64
|
-22.3 percentage change
Standard Deviation 20.3
|
-33.3 percentage change
Standard Deviation 15.5
|
4.4 percentage change
Standard Deviation 35.8
|
11.0 percentage change
Standard Deviation 29.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
-14.3 percentage change
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 76
|
-20.0 percentage change
Standard Deviation 7.0
|
-33.7 percentage change
Standard Deviation 16.2
|
24.6 percentage change
Standard Deviation 43.6
|
26.3 percentage change
Standard Deviation 34.1
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 88
|
-24.1 percentage change
Standard Deviation 0.0
|
-39.8 percentage change
Standard Deviation 15.9
|
28.2 percentage change
Standard Deviation 32.6
|
20.7 percentage change
Standard Deviation 28.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
-45.7 percentage change
Standard Deviation 7.5
|
60.0 percentage change
Standard Deviation NA
1 participant analyzed
|
44.8 percentage change
Standard Deviation 58.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 100
|
-31.0 percentage change
Standard Deviation 9.8
|
-46.4 percentage change
Standard Deviation 15.2
|
38.1 percentage change
Standard Deviation 38.1
|
9.9 percentage change
Standard Deviation 24.1
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 112
|
-27.6 percentage change
Standard Deviation NA
1 participant analyzed
|
-38.9 percentage change
Standard Deviation 11.3
|
41.4 percentage change
Standard Deviation 19.2
|
3.3 percentage change
Standard Deviation 24.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 124
|
—
|
-39.3 percentage change
Standard Deviation 5.1
|
35.0 percentage change
Standard Deviation NA
1 participant analyzed
|
25.2 percentage change
Standard Deviation 49.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
20.0 percentage change
Standard Deviation NA
1 participant analyzed
|
40.1 percentage change
Standard Deviation 79.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
55.0 percentage change
Standard Deviation NA
1 participant analyzed
|
25.5 percentage change
Standard Deviation 61.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
88.8 percentage change
Standard Deviation 3.0
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
-10.3 percentage change
Standard Deviation 65.0
|
—
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
End of Study
|
14.1 percentage change
Standard Deviation 38.7
|
-6.8 percentage change
Standard Deviation 34.6
|
-8.4 percentage change
Standard Deviation 15.0
|
4.7 percentage change
Standard Deviation 23.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
-15.7 percentage change
Standard Deviation 24.8
|
-9.7 percentage change
Standard Deviation 8.9
|
-10.8 percentage change
Standard Deviation 17.6
|
0.5 percentage change
Standard Deviation 13.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 52
|
-1.6 percentage change
Standard Deviation 32.9
|
-15.2 percentage change
Standard Deviation 18.1
|
14.5 percentage change
Standard Deviation 28.5
|
-1.4 percentage change
Standard Deviation 14.8
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 28
|
-27.4 percentage change
Standard Deviation 8.5
|
-12.4 percentage change
Standard Deviation 25.1
|
2.0 percentage change
Standard Deviation 29.3
|
6.4 percentage change
Standard Deviation 21.9
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
Week 40
|
-11.2 percentage change
Standard Deviation 21.4
|
-13.0 percentage change
Standard Deviation 24.0
|
4.0 percentage change
Standard Deviation 20.0
|
2.9 percentage change
Standard Deviation 18.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS
PDLB at Week 48
|
-21.7 percentage change
Standard Deviation 19.1
|
-1.2 percentage change
Standard Deviation 38.2
|
-4.8 percentage change
Standard Deviation 20.5
|
5.9 percentage change
Standard Deviation 15.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 16
|
-2.9 U/L
Standard Deviation 8.27
|
-0.1 U/L
Standard Deviation 4.02
|
1.1 U/L
Standard Deviation 6.10
|
0.7 U/L
Standard Deviation 5.23
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
-7.7 U/L
Standard Deviation 11.59
|
0.0 U/L
Standard Deviation 2.58
|
0.3 U/L
Standard Deviation 3.93
|
-0.4 U/L
Standard Deviation 3.81
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 28
|
-7.4 U/L
Standard Deviation 7.31
|
-1.3 U/L
Standard Deviation 4.68
|
10.2 U/L
Standard Deviation 27.92
|
0.1 U/L
Standard Deviation 5.49
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 40
|
-2.9 U/L
Standard Deviation 10.78
|
2.0 U/L
Standard Deviation 17.55
|
2.9 U/L
Standard Deviation 8.25
|
-0.9 U/L
Standard Deviation 3.65
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
PDLB at Week 48
|
-12.0 U/L
Standard Deviation 10.42
|
1.7 U/L
Standard Deviation 4.16
|
-1.0 U/L
Standard Deviation 5.22
|
1.2 U/L
Standard Deviation 6.40
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 52
|
-2.1 U/L
Standard Deviation 9.89
|
-0.9 U/L
Standard Deviation 8.46
|
6.3 U/L
Standard Deviation 15.92
|
-0.9 U/L
Standard Deviation 2.93
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 64
|
-8.8 U/L
Standard Deviation 10.24
|
-10.3 U/L
Standard Deviation 10.40
|
-0.7 U/L
Standard Deviation 4.42
|
1.9 U/L
Standard Deviation 7.70
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
-3.0 U/L
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 76
|
-6.3 U/L
Standard Deviation 4.73
|
-10.3 U/L
Standard Deviation 8.85
|
3.2 U/L
Standard Deviation 5.78
|
7.5 U/L
Standard Deviation 7.20
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 88
|
-6.7 U/L
Standard Deviation 5.69
|
-16.5 U/L
Standard Deviation 12.02
|
3.8 U/L
Standard Deviation 8.29
|
4.2 U/L
Standard Deviation 6.57
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
-11.0 U/L
Standard Deviation NA
1 participant analyzed
|
2.0 U/L
Standard Deviation NA
1 participant analyzed
|
5.0 U/L
Standard Deviation 5.66
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 100
|
-7.5 U/L
Standard Deviation 2.12
|
-21.5 U/L
Standard Deviation 13.44
|
1.5 U/L
Standard Deviation 2.12
|
0.0 U/L
Standard Deviation 4.76
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 112
|
-10.0 U/L
Standard Deviation NA
1 participant analyzed
|
-19.0 U/L
Standard Deviation 14.14
|
0.5 U/L
Standard Deviation 0.71
|
-2.0 U/L
Standard Deviation 7.00
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 124
|
—
|
-16.5 U/L
Standard Deviation 10.61
|
-1.0 U/L
Standard Deviation NA
1 participant analyzed
|
2.7 U/L
Standard Deviation 9.29
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
-2.0 U/L
Standard Deviation NA
1 participant analyzed
|
6.7 U/L
Standard Deviation 10.60
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
2.0 U/L
Standard Deviation NA
1 participant analyzed
|
1.0 U/L
Standard Deviation 11.14
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
10.5 U/L
Standard Deviation 0.71
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
-1.5 U/L
Standard Deviation 4.95
|
—
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS
End of Study
|
4.7 U/L
Standard Deviation 8.33
|
1.5 U/L
Standard Deviation 6.36
|
1.5 U/L
Standard Deviation 9.19
|
-0.2 U/L
Standard Deviation 3.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 16
|
-8.3 percentage change
Standard Deviation 20.0
|
2.6 percentage change
Standard Deviation 16.4
|
3.5 percentage change
Standard Deviation 22.5
|
2.5 percentage change
Standard Deviation 14.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
-16.9 percentage change
Standard Deviation 24.2
|
0.4 percentage change
Standard Deviation 7.8
|
1.5 percentage change
Standard Deviation 17.6
|
0.1 percentage change
Standard Deviation 9.8
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 28
|
-19.3 percentage change
Standard Deviation 19.3
|
-0.9 percentage change
Standard Deviation 14.5
|
26.8 percentage change
Standard Deviation 68.8
|
3.2 percentage change
Standard Deviation 17.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 40
|
-4.7 percentage change
Standard Deviation 26.9
|
10.6 percentage change
Standard Deviation 43.4
|
8.3 percentage change
Standard Deviation 21.7
|
-1.0 percentage change
Standard Deviation 11.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
PDLB at Week 48
|
-27.1 percentage change
Standard Deviation 20.1
|
6.0 percentage change
Standard Deviation 12.5
|
-2.0 percentage change
Standard Deviation 16.2
|
3.4 percentage change
Standard Deviation 19.2
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 52
|
-4.1 percentage change
Standard Deviation 27.2
|
1.9 percentage change
Standard Deviation 20.9
|
17.3 percentage change
Standard Deviation 40.3
|
-2.8 percentage change
Standard Deviation 9.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 64
|
-20.5 percentage change
Standard Deviation 23.3
|
-21.4 percentage change
Standard Deviation 15.4
|
-2.6 percentage change
Standard Deviation 16.8
|
9.5 percentage change
Standard Deviation 21.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
-5.9 percentage change
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 76
|
-17.1 percentage change
Standard Deviation 12.7
|
-22.2 percentage change
Standard Deviation 13.9
|
11.9 percentage change
Standard Deviation 22.6
|
30.3 percentage change
Standard Deviation 32.8
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 88
|
-16.4 percentage change
Standard Deviation 10.1
|
-30.6 percentage change
Standard Deviation 15.7
|
18.1 percentage change
Standard Deviation 34.7
|
21.1 percentage change
Standard Deviation 29.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
-26.8 percentage change
Standard Deviation NA
1 participant analyzed
|
7.4 percentage change
Standard Deviation NA
1 participant analyzed
|
31.9 percentage change
Standard Deviation 39.8
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 100
|
-24.6 percentage change
Standard Deviation 9.1
|
-40.5 percentage change
Standard Deviation 15.8
|
5.6 percentage change
Standard Deviation 7.9
|
5.2 percentage change
Standard Deviation 16.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 112
|
-34.5 percentage change
Standard Deviation NA
1 participant analyzed
|
-35.1 percentage change
Standard Deviation 18.7
|
2.5 percentage change
Standard Deviation 3.5
|
2.8 percentage change
Standard Deviation 27.0
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 124
|
—
|
-31.0 percentage change
Standard Deviation 12.8
|
-3.7 percentage change
Standard Deviation NA
1 participant analyzed
|
25.6 percentage change
Standard Deviation 53.1
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
7.4 percentage change
Standard Deviation NA
1 participant analyzed
|
21.8 percentage change
Standard Deviation 56.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
55.2 percentage change
Standard Deviation 25.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
-7.3 percentage change
Standard Deviation 26.9
|
—
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
End of Study
|
13.7 percentage change
Standard Deviation 24.6
|
10.5 percentage change
Standard Deviation 35.1
|
-2.7 percentage change
Standard Deviation 31.5
|
0.7 percentage change
Standard Deviation 17.1
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
-7.4 percentage change
Standard Deviation NA
1 participant analyzed
|
39.6 percentage change
Standard Deviation 70.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 16
|
-2.8 U/L
Standard Deviation 9.98
|
-4.3 U/L
Standard Deviation 6.50
|
-13.8 U/L
Standard Deviation 14.26
|
4.9 U/L
Standard Deviation 13.02
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
-9.7 U/L
Standard Deviation 8.62
|
-1.0 U/L
Standard Deviation 2.16
|
-11.7 U/L
Standard Deviation 14.83
|
3.6 U/L
Standard Deviation 6.62
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 28
|
0.6 U/L
Standard Deviation 12.29
|
-4.9 U/L
Standard Deviation 6.88
|
-8.4 U/L
Standard Deviation 13.53
|
0.7 U/L
Standard Deviation 5.51
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 40
|
-1.1 U/L
Standard Deviation 15.51
|
-7.1 U/L
Standard Deviation 6.36
|
-8.3 U/L
Standard Deviation 11.38
|
1.6 U/L
Standard Deviation 7.43
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
PDLB at Week 48
|
-10.5 U/L
Standard Deviation 16.62
|
-0.3 U/L
Standard Deviation 1.15
|
-2.8 U/L
Standard Deviation 15.69
|
1.2 U/L
Standard Deviation 2.56
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 52
|
-3.0 U/L
Standard Deviation 15.38
|
-7.6 U/L
Standard Deviation 8.26
|
-3.9 U/L
Standard Deviation 9.36
|
1.9 U/L
Standard Deviation 6.01
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 64
|
-8.3 U/L
Standard Deviation 22.23
|
-6.5 U/L
Standard Deviation 8.96
|
0.4 U/L
Standard Deviation 15.66
|
2.1 U/L
Standard Deviation 9.25
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 76
|
-14.0 U/L
Standard Deviation 23.39
|
-9.0 U/L
Standard Deviation 11.58
|
0.5 U/L
Standard Deviation 11.50
|
6.5 U/L
Standard Deviation 11.33
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 88
|
-14.7 U/L
Standard Deviation 21.13
|
-16.5 U/L
Standard Deviation 23.33
|
3.0 U/L
Standard Deviation 21.25
|
8.4 U/L
Standard Deviation 8.02
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
-11.5 U/L
Standard Deviation 13.44
|
2.0 U/L
Standard Deviation NA
1 participant analyzed
|
7.0 U/L
Standard Deviation 19.80
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 100
|
-23.0 U/L
Standard Deviation 26.87
|
-11.5 U/L
Standard Deviation 17.68
|
-2.0 U/L
Standard Deviation 2.83
|
8.8 U/L
Standard Deviation 12.04
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 112
|
-4.0 U/L
Standard Deviation NA
1 participant analyzed
|
-6.0 U/L
Standard Deviation 11.31
|
-2.0 U/L
Standard Deviation 4.24
|
5.0 U/L
Standard Deviation 13.75
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 124
|
—
|
-4.0 U/L
Standard Deviation 5.66
|
4.0 U/L
Standard Deviation NA
1 participant analyzed
|
4.3 U/L
Standard Deviation 9.24
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
2.0 U/L
Standard Deviation NA
1 participant analyzed
|
7.0 U/L
Standard Deviation 25.16
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
15.0 U/L
Standard Deviation NA
1 participant analyzed
|
11.0 U/L
Standard Deviation 26.46
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
23.0 U/L
Standard Deviation 26.87
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
-0.5 U/L
Standard Deviation 17.68
|
—
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
End of Study
|
1.8 U/L
Standard Deviation 10.40
|
-6.0 U/L
Standard Deviation 0.00
|
5.0 U/L
Standard Deviation 9.90
|
3.4 U/L
Standard Deviation 11.76
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
5.0 U/L
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 16
|
-0.5 percentage change
Standard Deviation 12.8
|
-5.6 percentage change
Standard Deviation 8.7
|
-17.7 percentage change
Standard Deviation 16.0
|
5.8 percentage change
Standard Deviation 14.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
-8.9 percentage change
Standard Deviation 6.1
|
-1.2 percentage change
Standard Deviation 2.8
|
-14.8 percentage change
Standard Deviation 16.8
|
5.9 percentage change
Standard Deviation 10.0
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 28
|
5.5 percentage change
Standard Deviation 20.1
|
-6.4 percentage change
Standard Deviation 9.3
|
-10.5 percentage change
Standard Deviation 16.1
|
1.0 percentage change
Standard Deviation 7.2
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 40
|
2.0 percentage change
Standard Deviation 16.9
|
-9.3 percentage change
Standard Deviation 8.2
|
-10.4 percentage change
Standard Deviation 14.9
|
2.2 percentage change
Standard Deviation 10.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
PDLB at Week 48
|
-8.5 percentage change
Standard Deviation 13.9
|
-0.4 percentage change
Standard Deviation 1.5
|
-3.3 percentage change
Standard Deviation 23.5
|
1.7 percentage change
Standard Deviation 3.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 52
|
0.1 percentage change
Standard Deviation 17.0
|
-9.7 percentage change
Standard Deviation 11.7
|
-4.9 percentage change
Standard Deviation 13.5
|
2.7 percentage change
Standard Deviation 8.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 64
|
-5.6 percentage change
Standard Deviation 18.4
|
-8.3 percentage change
Standard Deviation 10.8
|
-0.2 percentage change
Standard Deviation 22.5
|
3.9 percentage change
Standard Deviation 11.0
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
7.1 percentage change
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 76
|
-11.2 percentage change
Standard Deviation 18.2
|
-11.4 percentage change
Standard Deviation 13.5
|
0.7 percentage change
Standard Deviation 18.1
|
8.0 percentage change
Standard Deviation 13.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 88
|
-12.5 percentage change
Standard Deviation 15.9
|
-19.6 percentage change
Standard Deviation 27.8
|
3.2 percentage change
Standard Deviation 30.3
|
10.6 percentage change
Standard Deviation 9.5
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
-13.9 percentage change
Standard Deviation 15.7
|
2.9 percentage change
Standard Deviation NA
1 participant analyzed
|
7.6 percentage change
Standard Deviation 22.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 100
|
-19.4 percentage change
Standard Deviation 19.4
|
-13.6 percentage change
Standard Deviation 21.2
|
-2.5 percentage change
Standard Deviation 3.6
|
10.1 percentage change
Standard Deviation 13.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 112
|
-5.6 percentage change
Standard Deviation NA
1 participant analyzed
|
-6.9 percentage change
Standard Deviation 13.8
|
-2.4 percentage change
Standard Deviation 5.5
|
5.7 percentage change
Standard Deviation 15.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 124
|
—
|
-4.8 percentage change
Standard Deviation 6.7
|
5.8 percentage change
Standard Deviation NA
1 participant analyzed
|
4.7 percentage change
Standard Deviation 10.5
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
2.9 percentage change
Standard Deviation NA
1 participant analyzed
|
6.8 percentage change
Standard Deviation 29.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
21.7 percentage change
Standard Deviation NA
1 participant analyzed
|
11.5 percentage change
Standard Deviation 30.8
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
26.0 percentage change
Standard Deviation 30.0
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
4.6 percentage change
Standard Deviation 26.1
|
—
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS
End of Study
|
7.8 percentage change
Standard Deviation 18.2
|
-7.2 percentage change
Standard Deviation 1.8
|
7.1 percentage change
Standard Deviation 13.9
|
5.3 percentage change
Standard Deviation 12.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124,136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
End of Study
|
22.5 U/L
Standard Deviation 45.68
|
-0.5 U/L
Standard Deviation 0.71
|
-19.5 U/L
Standard Deviation 27.58
|
0.6 U/L
Standard Deviation 5.59
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 16
|
2.8 U/L
Standard Deviation 11.48
|
-4.3 U/L
Standard Deviation 5.90
|
-9.1 U/L
Standard Deviation 16.06
|
7.0 U/L
Standard Deviation 14.88
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
-3.7 U/L
Standard Deviation 16.80
|
-4.8 U/L
Standard Deviation 4.35
|
-4.3 U/L
Standard Deviation 4.93
|
1.1 U/L
Standard Deviation 4.62
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 28
|
-3.5 U/L
Standard Deviation 11.99
|
-5.3 U/L
Standard Deviation 5.57
|
-4.1 U/L
Standard Deviation 9.65
|
0.6 U/L
Standard Deviation 8.47
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 40
|
5.3 U/L
Standard Deviation 31.24
|
-3.8 U/L
Standard Deviation 9.29
|
0.9 U/L
Standard Deviation 16.88
|
0.6 U/L
Standard Deviation 7.69
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
PDLB at Week 48
|
-13.5 U/L
Standard Deviation 23.67
|
-5.3 U/L
Standard Deviation 4.16
|
-5.3 U/L
Standard Deviation 10.17
|
-0.5 U/L
Standard Deviation 10.48
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 52
|
7.3 U/L
Standard Deviation 36.39
|
-4.3 U/L
Standard Deviation 11.13
|
6.8 U/L
Standard Deviation 27.79
|
1.7 U/L
Standard Deviation 6.64
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 64
|
-16.0 U/L
Standard Deviation 13.22
|
-13.0 U/L
Standard Deviation 14.14
|
2.7 U/L
Standard Deviation 19.04
|
9.3 U/L
Standard Deviation 22.13
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
-3.0 U/L
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 76
|
-20.3 U/L
Standard Deviation 28.36
|
-13.3 U/L
Standard Deviation 15.48
|
-3.3 U/L
Standard Deviation 11.04
|
-0.3 U/L
Standard Deviation 10.19
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 88
|
-17.0 U/L
Standard Deviation 29.51
|
-19.0 U/L
Standard Deviation 25.46
|
2.0 U/L
Standard Deviation 7.81
|
7.2 U/L
Standard Deviation 4.97
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
-25.5 U/L
Standard Deviation 14.85
|
5.0 U/L
Standard Deviation NA
1 participant analyzed
|
3.5 U/L
Standard Deviation 0.71
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 100
|
-25.0 U/L
Standard Deviation 28.28
|
-24.5 U/L
Standard Deviation 21.92
|
6.5 U/L
Standard Deviation 4.95
|
-2.3 U/L
Standard Deviation 14.29
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 112
|
0.0 U/L
Standard Deviation NA
1 participant analyzed
|
-21.5 U/L
Standard Deviation 9.19
|
5.5 U/L
Standard Deviation 4.95
|
4.3 U/L
Standard Deviation 10.41
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 124
|
—
|
-50.4 U/L
Standard Deviation 2.6
|
8.0 U/L
Standard Deviation NA
1 participant analyzed
|
1.7 U/L
Standard Deviation 9.61
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
7.0 U/L
Standard Deviation NA
1 participant analyzed
|
5.0 U/L
Standard Deviation 7.55
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
10.0 U/L
Standard Deviation NA
1 participant analyzed
|
-0.3 U/L
Standard Deviation 11.59
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
3.0 U/L
Standard Deviation 4.24
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
5.0 U/L
Standard Deviation 4.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 16
|
5.9 percentage change
Standard Deviation 18.9
|
-9.7 percentage change
Standard Deviation 12.7
|
-14.8 percentage change
Standard Deviation 18.5
|
13.9 percentage change
Standard Deviation 31.0
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
0.8 percentage change
Standard Deviation 32.2
|
-9.1 percentage change
Standard Deviation 8.6
|
-13.2 percentage change
Standard Deviation 13.6
|
4.7 percentage change
Standard Deviation 15.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 28
|
-2.2 percentage change
Standard Deviation 21.5
|
-12.0 percentage change
Standard Deviation 11.7
|
-3.2 percentage change
Standard Deviation 22.2
|
6.8 percentage change
Standard Deviation 21.5
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 40
|
14.4 percentage change
Standard Deviation 52.4
|
-6.4 percentage change
Standard Deviation 18.3
|
-1.7 percentage change
Standard Deviation 31.6
|
7.4 percentage change
Standard Deviation 14.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
PDLB at Week 48
|
-8.9 percentage change
Standard Deviation 36.3
|
-13.3 percentage change
Standard Deviation 7.2
|
-10.4 percentage change
Standard Deviation 30.9
|
8.1 percentage change
Standard Deviation 17.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 52
|
26.7 percentage change
Standard Deviation 69.5
|
-3.5 percentage change
Standard Deviation 25.1
|
6.2 percentage change
Standard Deviation 35.2
|
5.1 percentage change
Standard Deviation 15.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 64
|
-23.0 percentage change
Standard Deviation 6.7
|
-22.8 percentage change
Standard Deviation 17.8
|
20.7 percentage change
Standard Deviation 69.3
|
13.1 percentage change
Standard Deviation 24.9
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
-6.7 percentage change
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 76
|
-22.2 percentage change
Standard Deviation 13.6
|
-23.1 percentage change
Standard Deviation 18.9
|
-0.9 percentage change
Standard Deviation 38.4
|
9.5 percentage change
Standard Deviation 13.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 88
|
13.7 percentage change
Standard Deviation 21.1
|
-26.8 percentage change
Standard Deviation 34.7
|
15.6 percentage change
Standard Deviation 39.5
|
17.9 percentage change
Standard Deviation 15.1
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
-42.0 percentage change
Standard Deviation 11.2
|
25.0 percentage change
Standard Deviation NA
1 participant analyzed
|
11.9 percentage change
Standard Deviation 2.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 100
|
-23.4 percentage change
Standard Deviation 11.7
|
-38.0 percentage change
Standard Deviation 24.8
|
33.8 percentage change
Standard Deviation 22.9
|
6.1 percentage change
Standard Deviation 24.2
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 112
|
0.0 percentage change
Standard Deviation NA
1 participant analyzed
|
-36.5 percentage change
Standard Deviation 3.4
|
28.4 percentage change
Standard Deviation 23.5
|
16.0 percentage change
Standard Deviation 32.9
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 124
|
—
|
-50.4 percentage change
Standard Deviation 2.6
|
40.0 percentage change
Standard Deviation NA
1 participant analyzed
|
8.1 percentage change
Standard Deviation 28.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
35.0 percentage change
Standard Deviation NA
1 participant analyzed
|
18.0 percentage change
Standard Deviation 23.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
50.0 percentage change
Standard Deviation NA
1 participant analyzed
|
2.9 percentage change
Standard Deviation 33.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
10.0 percentage change
Standard Deviation 14.1
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
30.7 percentage change
Standard Deviation 32.1
|
—
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS
End of Study
|
39.2 percentage change
Standard Deviation 78.5
|
-2.2 percentage change
Standard Deviation 3.1
|
-17.1 percentage change
Standard Deviation 24.2
|
6.7 percentage change
Standard Deviation 18.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124,136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 16
|
0.079 mg/dL
Standard Deviation 0.146
|
0.098 mg/dL
Standard Deviation 0.369
|
-0.051 mg/dL
Standard Deviation 0.241
|
-0.004 mg/dL
Standard Deviation 0.208
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
0.060 mg/dL
Standard Deviation 0.075
|
0.163 mg/dL
Standard Deviation 0.456
|
-0.040 mg/dL
Standard Deviation 0.182
|
-0.118 mg/dL
Standard Deviation 0.105
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 28
|
0.109 mg/dL
Standard Deviation 0.149
|
0.171 mg/dL
Standard Deviation 0.470
|
0.053 mg/dL
Standard Deviation 0.230
|
0.012 mg/dL
Standard Deviation 0.272
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 40
|
0.083 mg/dL
Standard Deviation 0.115
|
0.164 mg/dL
Standard Deviation 0.437
|
0.017 mg/dL
Standard Deviation 0.092
|
0.062 mg/dL
Standard Deviation 0.434
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 48
|
0.043 mg/dL
Standard Deviation 0.109
|
-0.070 mg/dL
Standard Deviation 0.594
|
0.098 mg/dL
Standard Deviation 0.252
|
-0.085 mg/dL
Standard Deviation 0.178
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 52
|
-0.023 mg/dL
Standard Deviation 0.203
|
0.129 mg/dL
Standard Deviation 0.362
|
0.086 mg/dL
Standard Deviation 0.165
|
0.099 mg/dL
Standard Deviation 0.230
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 64
|
0.020 mg/dL
Standard Deviation 0.210
|
0.188 mg/dL
Standard Deviation 0.235
|
0.006 mg/dL
Standard Deviation 0.208
|
-0.086 mg/dL
Standard Deviation 0.188
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
-0.420 mg/dL
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 76
|
0.110 mg/dL
Standard Deviation 0.105
|
0.248 mg/dL
Standard Deviation 0.357
|
-0.043 mg/dL
Standard Deviation 0.206
|
-0.018 mg/dL
Standard Deviation 0.198
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 88
|
0.247 mg/dL
Standard Deviation 0.375
|
0.105 mg/dL
Standard Deviation 0.035
|
0.002 mg/dL
Standard Deviation 0.131
|
-0.050 mg/dL
Standard Deviation 0.131
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
0.020 mg/dL
Standard Deviation 0.127
|
0.170 mg/dL
Standard Deviation NA
1 participant analyzed
|
0.065 mg/dL
Standard Deviation 0.035
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 100
|
-0.040 mg/dL
Standard Deviation 0.099
|
-0.055 mg/dL
Standard Deviation 0.106
|
0.090 mg/dL
Standard Deviation 0.042
|
0.003 mg/dL
Standard Deviation 0.203
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 112
|
-0.020 mg/dL
Standard Deviation NA
1 participant analyzed
|
-0.010 mg/dL
Standard Deviation 0.269
|
0.100 mg/dL
Standard Deviation 0.141
|
-0.060 mg/dL
Standard Deviation 0.249
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 124
|
—
|
-0.190 mg/dL
Standard Deviation 0.071
|
0.130 mg/dL
Standard Deviation NA
1 participant analyzed
|
-0.037 mg/dL
Standard Deviation 0.085
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
0.100 mg/dL
Standard Deviation NA
1 participant analyzed
|
0.003 mg/dL
Standard Deviation 0.185
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
0.070 mg/dL
Standard Deviation NA
1 participant analyzed
|
-0.087 mg/dL
Standard Deviation 0.199
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
End of Study
|
0.170 mg/dL
Standard Deviation 0.123
|
0.050 mg/dL
Standard Deviation 0.113
|
0.025 mg/dL
Standard Deviation 0.205
|
0.154 mg/dL
Standard Deviation 0.082
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
-0.090 mg/dL
Standard Deviation 0.028
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
-0.010 mg/dL
Standard Deviation 0.014
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 16
|
19.2 percentage change
Standard Deviation 38.5
|
15.6 percentage change
Standard Deviation 41.7
|
3.4 percentage change
Standard Deviation 44.1
|
1.0 percentage change
Standard Deviation 28.0
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
16.4 percentage change
Standard Deviation 19.2
|
25.3 percentage change
Standard Deviation 49.7
|
3.1 percentage change
Standard Deviation 33.1
|
-16.3 percentage change
Standard Deviation 12.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 28
|
26.7 percentage change
Standard Deviation 36.1
|
27.8 percentage change
Standard Deviation 51.4
|
15.8 percentage change
Standard Deviation 36.8
|
1.3 percentage change
Standard Deviation 37.5
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 40
|
20.6 percentage change
Standard Deviation 27.8
|
30.2 percentage change
Standard Deviation 51.4
|
10.0 percentage change
Standard Deviation 21.6
|
7.8 percentage change
Standard Deviation 46.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 48
|
11.8 percentage change
Standard Deviation 27.8
|
10.8 percentage change
Standard Deviation 68.2
|
36.5 percentage change
Standard Deviation 52.2
|
-10.9 percentage change
Standard Deviation 29.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 52
|
-8.3 percentage change
Standard Deviation 36.6
|
27.5 percentage change
Standard Deviation 48.8
|
25.4 percentage change
Standard Deviation 29.4
|
15.5 percentage change
Standard Deviation 36.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 64
|
10.3 percentage change
Standard Deviation 51.0
|
28.5 percentage change
Standard Deviation 38.0
|
10.0 percentage change
Standard Deviation 35.7
|
-13.3 percentage change
Standard Deviation 28.1
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
-60.0 percentage change
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 76
|
18.1 percentage change
Standard Deviation 16.1
|
40.1 percentage change
Standard Deviation 57.1
|
0.3 percentage change
Standard Deviation 31.6
|
-1.0 percentage change
Standard Deviation 33.2
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 88
|
38.0 percentage change
Standard Deviation 53.7
|
13.1 percentage change
Standard Deviation 1.7
|
5.4 percentage change
Standard Deviation 29.3
|
-7.6 percentage change
Standard Deviation 21.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
0.8 percentage change
Standard Deviation 15.9
|
39.5 percentage change
Standard Deviation NA
1 participant analyzed
|
9.2 percentage change
Standard Deviation 1.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 100
|
-11.9 percentage change
Standard Deviation 25.2
|
-8.6 percentage change
Standard Deviation 15.3
|
25.1 percentage change
Standard Deviation 4.0
|
0.4 percentage change
Standard Deviation 31.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 112
|
-5.4 percentage change
Standard Deviation NA
1 participant analyzed
|
-5.0 percentage change
Standard Deviation 35.1
|
37.0 percentage change
Standard Deviation 52.4
|
-5.8 percentage change
Standard Deviation 30.8
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 124
|
—
|
-23.6 percentage change
Standard Deviation 3.9
|
30.2 percentage change
Standard Deviation NA
1 participant analyzed
|
-5.7 percentage change
Standard Deviation 12.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
23.3 percentage change
Standard Deviation NA
1 participant analyzed
|
4.4 percentage change
Standard Deviation 25.2
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
16.3 percentage change
Standard Deviation NA
1 participant analyzed
|
-7.6 percentage change
Standard Deviation 29.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
-13.4 percentage change
Standard Deviation 0.9
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
-2.9 percentage change
Standard Deviation 4.2
|
—
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS
End of Study
|
41.8 percentage change
Standard Deviation 36.4
|
11.5 percentage change
Standard Deviation 26.4
|
25.0 percentage change
Standard Deviation 69.2
|
26.8 percentage change
Standard Deviation 16.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 16
|
0.016 mg/dL
Standard Deviation 0.049
|
-0.006 mg/dL
Standard Deviation 0.095
|
0.005 mg/dL
Standard Deviation 0.094
|
0.010 mg/dL
Standard Deviation 0.061
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
0.013 mg/dL
Standard Deviation 0.029
|
0.055 mg/dL
Standard Deviation 0.157
|
-0.030 mg/dL
Standard Deviation 0.081
|
-0.028 mg/dL
Standard Deviation 0.041
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 28
|
0.029 mg/dL
Standard Deviation 0.055
|
0.039 mg/dL
Standard Deviation 0.140
|
0.004 mg/dL
Standard Deviation 0.062
|
0.008 mg/dL
Standard Deviation 0.073
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 40
|
0.026 mg/dL
Standard Deviation 0.050
|
0.045 mg/dL
Standard Deviation 0.160
|
-0.005 mg/dL
Standard Deviation 0.063
|
0.020 mg/dL
Standard Deviation 0.125
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 48
|
-0.005 mg/dL
Standard Deviation 0.041
|
-0.080 mg/dL
Standard Deviation 0.210
|
0.007 mg/dL
Standard Deviation 0.087
|
-0.038 mg/dL
Standard Deviation 0.065
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 52
|
-0.024 mg/dL
Standard Deviation 0.080
|
0.034 mg/dL
Standard Deviation 0.107
|
0.015 mg/dL
Standard Deviation 0.052
|
0.031 mg/dL
Standard Deviation 0.058
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 64
|
-0.008 mg/dL
Standard Deviation 0.081
|
0.053 mg/dL
Standard Deviation 0.061
|
-0.007 mg/dL
Standard Deviation 0.076
|
-0.019 mg/dL
Standard Deviation 0.043
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
-46.2 mg/dL
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 76
|
0.027 mg/dL
Standard Deviation 0.029
|
0.098 mg/dL
Standard Deviation 0.069
|
-0.033 mg/dL
Standard Deviation 0.073
|
0.027 mg/dL
Standard Deviation 0.057
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 88
|
0.053 mg/dL
Standard Deviation 0.114
|
0.070 mg/dL
Standard Deviation 0.014
|
-0.007 mg/dL
Standard Deviation 0.043
|
0.012 mg/dL
Standard Deviation 0.026
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
0.030 mg/dL
Standard Deviation NA
1 participant analyzed
|
0.080 mg/dL
Standard Deviation NA
1 participant analyzed
|
0.045 mg/dL
Standard Deviation 0.035
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 100
|
0.000 mg/dL
Standard Deviation 0.028
|
0.010 mg/dL
Standard Deviation 0.014
|
0.050 mg/dL
Standard Deviation 0.028
|
0.018 mg/dL
Standard Deviation 0.052
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 112
|
0.020 mg/dL
Standard Deviation NA
1 participant analyzed
|
0.025 mg/dL
Standard Deviation 0.049
|
0.055 mg/dL
Standard Deviation 0.035
|
0.007 mg/dL
Standard Deviation 0.061
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 124
|
—
|
-0.040 mg/dL
Standard Deviation 0.057
|
0.070 mg/dL
Standard Deviation NA
1 participant analyzed
|
0.020 mg/dL
Standard Deviation 0.035
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
0.030 mg/dL
Standard Deviation NA
1 participant analyzed
|
0.013 mg/dL
Standard Deviation 0.046
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
0.050 mg/dL
Standard Deviation NA
1 participant analyzed
|
-0.003 mg/dL
Standard Deviation 0.090
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
End of Study
|
0.050 mg/dL
Standard Deviation 0.060
|
0.010 mg/dL
Standard Deviation 0.028
|
0.028 mg/dL
Standard Deviation 0.138
|
0.053 mg/dL
Standard Deviation 0.044
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
0.015 mg/dL
Standard Deviation 0.007
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
0.005 mg/dL
Standard Deviation 0.007
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 16
|
5.9 percentage change
Standard Deviation 30.1
|
1.5 percentage change
Standard Deviation 31.2
|
29.1 percentage change
Standard Deviation 67.6
|
15.1 percentage change
Standard Deviation 58.9
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
11.0 percentage change
Standard Deviation 16.4
|
22.4 percentage change
Standard Deviation 50.9
|
-0.1 percentage change
Standard Deviation 33.0
|
-8.8 percentage change
Standard Deviation 17.0
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 28
|
19.0 percentage change
Standard Deviation 28.3
|
15.4 percentage change
Standard Deviation 37.3
|
21.2 percentage change
Standard Deviation 61.9
|
10.1 percentage change
Standard Deviation 44.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 40
|
17.9 percentage change
Standard Deviation 27.5
|
16.7 percentage change
Standard Deviation 44.9
|
15.5 percentage change
Standard Deviation 47.6
|
14.3 percentage change
Standard Deviation 50.2
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 48
|
2.9 percentage change
Standard Deviation 19.5
|
-9.9 percentage change
Standard Deviation 63.0
|
19.3 percentage change
Standard Deviation 48.7
|
-11.9 percentage change
Standard Deviation 23.9
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 52
|
-12.1 percentage change
Standard Deviation 34.3
|
17.8 percentage change
Standard Deviation 35.1
|
25.1 percentage change
Standard Deviation 47.0
|
19.6 percentage change
Standard Deviation 38.5
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 64
|
4.4 percentage change
Standard Deviation 39.7
|
18.9 percentage change
Standard Deviation 26.7
|
8.2 percentage change
Standard Deviation 37.3
|
-8.6 percentage change
Standard Deviation 16.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
-46.2 percentage change
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 76
|
9.9 percentage change
Standard Deviation 7.4
|
33.4 percentage change
Standard Deviation 20.2
|
-5.4 percentage change
Standard Deviation 30.0
|
11.4 percentage change
Standard Deviation 21.5
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 88
|
18.2 percentage change
Standard Deviation 35.0
|
24.9 percentage change
Standard Deviation 14.0
|
-3.3 percentage change
Standard Deviation 30.3
|
5.6 percentage change
Standard Deviation 12.1
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
7.5 percentage change
Standard Deviation NA
1 participant analyzed
|
53.3 percentage change
Standard Deviation NA
1 participant analyzed
|
17.1 percentage change
Standard Deviation 10.0
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 100
|
-3.8 percentage change
Standard Deviation 16.3
|
4.3 percentage change
Standard Deviation 6.1
|
37.0 percentage change
Standard Deviation 13.7
|
7.5 percentage change
Standard Deviation 23.2
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 112
|
15.4 percentage change
Standard Deviation NA
1 participant analyzed
|
5.3 percentage change
Standard Deviation 13.7
|
46.4 percentage change
Standard Deviation 37.3
|
4.1 percentage change
Standard Deviation 22.5
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 124
|
—
|
-10.0 percentage change
Standard Deviation 14.1
|
46.7 percentage change
Standard Deviation NA
1 participant analyzed
|
7.7 percentage change
Standard Deviation 13.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
20.0 percentage change
Standard Deviation NA
1 participant analyzed
|
7.2 percentage change
Standard Deviation 18.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
33.3 percentage change
Standard Deviation NA
1 participant analyzed
|
3.4 percentage change
Standard Deviation 38.5
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
6.7 percentage change
Standard Deviation 4.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
2.4 percentage change
Standard Deviation 3.4
|
—
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS
End of Study
|
34.3 percentage change
Standard Deviation 45.6
|
5.4 percentage change
Standard Deviation 14.7
|
96.1 percentage change
Standard Deviation 185.5
|
40.8 percentage change
Standard Deviation 46.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 40
|
-0.021 ratio
Standard Deviation 0.113
|
-0.024 ratio
Standard Deviation 0.099
|
-0.022 ratio
Standard Deviation 0.125
|
0.034 ratio
Standard Deviation 0.143
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
PDLB at Week 48
|
-0.038 ratio
Standard Deviation 0.054
|
-0.067 ratio
Standard Deviation 0.150
|
-0.023 ratio
Standard Deviation 0.121
|
0.022 ratio
Standard Deviation 0.048
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
0.045 ratio
Standard Deviation 0.092
|
—
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
End of Study
|
-0.115 ratio
Standard Deviation 0.170
|
-0.045 ratio
Standard Deviation 0.049
|
-0.035 ratio
Standard Deviation 0.021
|
-0.106 ratio
Standard Deviation 0.149
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 16
|
-0.012 ratio
Standard Deviation 0.054
|
-0.006 ratio
Standard Deviation 0.093
|
0.011 ratio
Standard Deviation 0.068
|
0.055 ratio
Standard Deviation 0.180
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
0.047 ratio
Standard Deviation 0.111
|
-0.085 ratio
Standard Deviation 0.093
|
-0.017 ratio
Standard Deviation 0.117
|
0.036 ratio
Standard Deviation 0.104
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 28
|
-0.054 ratio
Standard Deviation 0.148
|
-0.059 ratio
Standard Deviation 0.109
|
-0.040 ratio
Standard Deviation 0.107
|
-0.014 ratio
Standard Deviation 0.167
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 52
|
-0.094 ratio
Standard Deviation 0.139
|
-0.053 ratio
Standard Deviation 0.057
|
-0.034 ratio
Standard Deviation 0.076
|
-0.002 ratio
Standard Deviation 0.076
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 64
|
-0.038 ratio
Standard Deviation 0.089
|
-0.100 ratio
Standard Deviation 0.082
|
-0.043 ratio
Standard Deviation 0.130
|
0.012 ratio
Standard Deviation 0.055
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
0.040 ratio
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 76
|
-0.033 ratio
Standard Deviation 0.049
|
-0.110 ratio
Standard Deviation 0.130
|
-0.065 ratio
Standard Deviation 0.136
|
0.020 ratio
Standard Deviation 0.046
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 88
|
-0.053 ratio
Standard Deviation 0.040
|
-0.225 ratio
Standard Deviation 0.177
|
-0.004 ratio
Standard Deviation 0.083
|
0.038 ratio
Standard Deviation 0.026
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
-0.195 ratio
Standard Deviation 0.134
|
0.090 ratio
Standard Deviation NA
1 participant analyzed
|
0.045 ratio
Standard Deviation 0.078
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 100
|
0.000 ratio
Standard Deviation 0.014
|
-0.225 ratio
Standard Deviation 0.163
|
-0.020 ratio
Standard Deviation 0.099
|
0.063 ratio
Standard Deviation 0.045
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 112
|
0.050 ratio
Standard Deviation NA
1 participant analyzed
|
-0.240 ratio
Standard Deviation 0.184
|
0.035 ratio
Standard Deviation 0.078
|
0.047 ratio
Standard Deviation 0.083
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 124
|
—
|
-0.175 ratio
Standard Deviation 0.247
|
0.050 ratio
Standard Deviation NA
1 participant analyzed
|
0.053 ratio
Standard Deviation 0.021
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
0.070 ratio
Standard Deviation NA
1 participant analyzed
|
0.043 ratio
Standard Deviation 0.032
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
0.080 ratio
Standard Deviation NA
1 participant analyzed
|
0.040 ratio
Standard Deviation 0.026
|
—
|
—
|
|
Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
0.070 ratio
Standard Deviation 0.042
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 16
|
-1.0 percentage change
Standard Deviation 4.8
|
-0.7 percentage change
Standard Deviation 7.7
|
1.2 percentage change
Standard Deviation 6.4
|
2.6 percentage change
Standard Deviation 8.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 16 + 24 H
|
4.4 percentage change
Standard Deviation 10.3
|
-7.0 percentage change
Standard Deviation 6.9
|
-1.0 percentage change
Standard Deviation 10.2
|
3.5 percentage change
Standard Deviation 9.9
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 28
|
-3.9 percentage change
Standard Deviation 11.8
|
-4.9 percentage change
Standard Deviation 8.5
|
-3.3 percentage change
Standard Deviation 9.1
|
1.2 percentage change
Standard Deviation 8.7
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 40
|
-1.2 percentage change
Standard Deviation 9.6
|
-1.6 percentage change
Standard Deviation 7.8
|
-1.6 percentage change
Standard Deviation 11.3
|
3.7 percentage change
Standard Deviation 13.0
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
PDLB at Week 48
|
-3.2 percentage change
Standard Deviation 4.7
|
-5.5 percentage change
Standard Deviation 13.3
|
-1.5 percentage change
Standard Deviation 10.3
|
2.2 percentage change
Standard Deviation 4.8
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 52
|
-7.7 percentage change
Standard Deviation 10.2
|
-4.7 percentage change
Standard Deviation 4.9
|
-2.9 percentage change
Standard Deviation 6.3
|
0.3 percentage change
Standard Deviation 6.9
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 64
|
-3.2 percentage change
Standard Deviation 7.9
|
-8.4 percentage change
Standard Deviation 7.1
|
-3.2 percentage change
Standard Deviation 11.4
|
1.3 percentage change
Standard Deviation 5.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
3.9 percentage change
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 76
|
-2.8 percentage change
Standard Deviation 4.0
|
-8.8 percentage change
Standard Deviation 9.9
|
-5.3 percentage change
Standard Deviation 11.8
|
2.0 percentage change
Standard Deviation 4.6
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 88
|
-4.7 percentage change
Standard Deviation 3.1
|
-17.9 percentage change
Standard Deviation 12.5
|
-0.3 percentage change
Standard Deviation 8.0
|
3.7 percentage change
Standard Deviation 2.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
PDLB at Week 96
|
—
|
-15.6 percentage change
Standard Deviation 9.2
|
9.0 percentage change
Standard Deviation NA
1 participant analyzed
|
4.6 percentage change
Standard Deviation 7.8
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 100
|
0.0 percentage change
Standard Deviation 1.4
|
-18.0 percentage change
Standard Deviation 11.3
|
-1.8 percentage change
Standard Deviation 9.6
|
6.2 percentage change
Standard Deviation 4.5
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 112
|
4.9 percentage change
Standard Deviation NA
1 participant analyzed
|
-19.1 percentage change
Standard Deviation 12.9
|
3.5 percentage change
Standard Deviation 7.7
|
4.7 percentage change
Standard Deviation 8.4
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 124
|
—
|
-13.4 percentage change
Standard Deviation 18.9
|
5.0 percentage change
Standard Deviation NA
1 participant analyzed
|
5.3 percentage change
Standard Deviation 2.1
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 136
|
—
|
—
|
7.0 percentage change
Standard Deviation NA
1 participant analyzed
|
4.3 percentage change
Standard Deviation 3.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 148
|
—
|
—
|
8.0 percentage change
Standard Deviation NA
1 participant analyzed
|
3.9 percentage change
Standard Deviation 2.5
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Week 160
|
—
|
—
|
—
|
7.0 percentage change
Standard Deviation 4.3
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
Early Termination
|
—
|
—
|
4.8 percentage change
Standard Deviation 9.4
|
—
|
—
|
—
|
|
Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS
End of Study
|
-9.1 percentage change
Standard Deviation 12.7
|
-4.3 percentage change
Standard Deviation 4.9
|
-3.6 percentage change
Standard Deviation 2.0
|
-5.8 percentage change
Standard Deviation 4.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 16, 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Full Analysis Set: All randomized participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 2
|
-125.511 μg/mL
Standard Deviation 59.955
|
-156.714 μg/mL
Standard Deviation 58.127
|
-169.044 μg/mL
Standard Deviation 40.328
|
16.929 μg/mL
Standard Deviation 37.723
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 4
|
-146.267 μg/mL
Standard Deviation 68.511
|
-178.413 μg/mL
Standard Deviation 58.821
|
-181.389 μg/mL
Standard Deviation 41.857
|
-0.429 μg/mL
Standard Deviation 18.826
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 6
|
-176.100 μg/mL
Standard Deviation 47.242
|
-192.719 μg/mL
Standard Deviation 65.087
|
-188.781 μg/mL
Standard Deviation 43.539
|
7.000 μg/mL
Standard Deviation 26.712
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 16
|
-158.650 μg/mL
Standard Deviation 50.266
|
-185.213 μg/mL
Standard Deviation 58.059
|
-182.240 μg/mL
Standard Deviation 45.710
|
10.286 μg/mL
Standard Deviation 29.374
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 28
|
-123.288 μg/mL
Standard Deviation 62.112
|
-174.275 μg/mL
Standard Deviation 57.293
|
-175.136 μg/mL
Standard Deviation 52.838
|
-0.500 μg/mL
Standard Deviation 25.035
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 40
|
-122.288 μg/mL
Standard Deviation 70.057
|
-165.763 μg/mL
Standard Deviation 59.312
|
-164.629 μg/mL
Standard Deviation 63.830
|
1.429 μg/mL
Standard Deviation 20.137
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
PDLB at Week 48
|
-189.850 μg/mL
Standard Deviation 64.556
|
-150.900 μg/mL
Standard Deviation 17.521
|
-194.535 μg/mL
Standard Deviation 51.128
|
14.333 μg/mL
Standard Deviation 38.754
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 52
|
-116.188 μg/mL
Standard Deviation 72.983
|
-157.300 μg/mL
Standard Deviation 56.023
|
-165.741 μg/mL
Standard Deviation 64.535
|
-13.643 μg/mL
Standard Deviation 36.527
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 64
|
-187.325 μg/mL
Standard Deviation 94.397
|
-191.150 μg/mL
Standard Deviation 80.589
|
-190.284 μg/mL
Standard Deviation 45.070
|
0.333 μg/mL
Standard Deviation 27.208
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
-6.00 μg/mL
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 76
|
-164.067 μg/mL
Standard Deviation 65.875
|
-189.225 μg/mL
Standard Deviation 91.259
|
-177.060 μg/mL
Standard Deviation 49.718
|
-9.500 μg/mL
Standard Deviation 20.907
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 88
|
-142.767 μg/mL
Standard Deviation 89.632
|
-260.200 μg/mL
Standard Deviation 82.166
|
-186.116 μg/mL
Standard Deviation 44.539
|
-1.800 μg/mL
Standard Deviation 28.490
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
PDLB at Week 96
|
—
|
-271.100 μg/mL
Standard Deviation 90.793
|
-194.160 μg/mL
Standard Deviation NA
1 participant analyzed
|
-35.000 μg/mL
Standard Deviation 15.556
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 100
|
-204.650 μg/mL
Standard Deviation 18.597
|
-244.100 μg/mL
Standard Deviation 91.358
|
-187.650 μg/mL
Standard Deviation 3.323
|
-60.725 μg/mL
Standard Deviation 84.824
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 112
|
-233.000 μg/mL
Standard Deviation NA
1 participant analyzed
|
-263.100 μg/mL
Standard Deviation 91.358
|
-182.550 μg/mL
Standard Deviation 3.182
|
-22.333 μg/mL
Standard Deviation 22.679
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 124
|
—
|
-237.650 μg/mL
Standard Deviation 102.743
|
-183.000 μg/mL
Standard Deviation NA
1 participant analyzed
|
-26.000 μg/mL
Standard Deviation 22.271
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 136
|
—
|
—
|
-183.300 μg/mL
Standard Deviation NA
1 participant analyzed
|
-8.000 μg/mL
Standard Deviation 22.650
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 148
|
—
|
—
|
-89.1 μg/mL
Standard Deviation NA
1 participant analyzed
|
9.333 μg/mL
Standard Deviation 11.719
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Week 160
|
—
|
—
|
—
|
7.500 μg/mL
Standard Deviation 9.192
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
Early Termination
|
—
|
—
|
-192.240 μg/mL
Standard Deviation 81.657
|
—
|
—
|
—
|
|
Absolute Change in Serum Z-AAT Over Time Through EOS
End of Study
|
-42.750 μg/mL
Standard Deviation 7.089
|
-103.533 μg/mL
Standard Deviation 3.443
|
-39.000 μg/mL
Standard Deviation 1.414
|
19.750 μg/mL
Standard Deviation 30.966
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 16, 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)Population: Full Analysis Set: All randomized participants who received at least one dose of study drug; participants with an assessment at given time point.
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 2
|
-50.8 percentage change
Standard Deviation 21.9
|
-69.9 percentage change
Standard Deviation 11.4
|
-85.5 percentage change
Standard Deviation 4.8
|
10.0 percentage change
Standard Deviation 23.8
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 4
|
-60.0 percentage change
Standard Deviation 24.6
|
-82.2 percentage change
Standard Deviation 7.1
|
-91.8 percentage change
Standard Deviation 2.5
|
0.5 percentage change
Standard Deviation 8.7
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 6
|
-71.9 percentage change
Standard Deviation 14.0
|
-88.4 percentage change
Standard Deviation 5.0
|
-95.5 percentage change
Standard Deviation 1.9
|
3.4 percentage change
Standard Deviation 11.4
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 16
|
-62.4 percentage change
Standard Deviation 17.0
|
-85.7 percentage change
Standard Deviation 7.6
|
-91.9 percentage change
Standard Deviation 5.8
|
4.3 percentage change
Standard Deviation 12.2
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 28
|
-48.2 percentage change
Standard Deviation 20.6
|
-80.6 percentage change
Standard Deviation 7.9
|
-87.6 percentage change
Standard Deviation 10.4
|
0.1 percentage change
Standard Deviation 11.2
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 40
|
-48.3 percentage change
Standard Deviation 23.4
|
-76.5 percentage change
Standard Deviation 10.5
|
-81.3 percentage change
Standard Deviation 18.8
|
0.3 percentage change
Standard Deviation 9.2
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
PDLB at Week 48
|
-73.9 percentage change
Standard Deviation 16.7
|
-89.2 percentage change
Standard Deviation 2.5
|
-93.9 percentage change
Standard Deviation 5.0
|
8.7 percentage change
Standard Deviation 19.0
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 52
|
-45.9 percentage change
Standard Deviation 24.7
|
-73.0 percentage change
Standard Deviation 12.9
|
-82.1 percentage change
Standard Deviation 20.5
|
-5.3 percentage change
Standard Deviation 14.9
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 64
|
-70.1 percentage change
Standard Deviation 23.5
|
-77.6 percentage change
Standard Deviation 9.5
|
-92.2 percentage change
Standard Deviation 5.7
|
2.1 percentage change
Standard Deviation 12.3
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
PDLB at Week 72
|
—
|
—
|
—
|
-2.4 percentage change
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 76
|
-71.8 percentage change
Standard Deviation 19.6
|
-75.1 percentage change
Standard Deviation 9.0
|
-88.8 percentage change
Standard Deviation 10.1
|
-2.4 percentage change
Standard Deviation 9.3
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 88
|
-60.1 percentage change
Standard Deviation 32.6
|
-77.8 percentage change
Standard Deviation 7.2
|
-90.3 percentage change
Standard Deviation 6.3
|
0.5 percentage change
Standard Deviation 11.4
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
PDLB at Week 96
|
—
|
-80.9 percentage change
Standard Deviation 9.1
|
-95.6 percentage change
Standard Deviation NA
1 participant analyzed
|
-11.7 percentage change
Standard Deviation 4.2
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 100
|
-82.5 percentage change
Standard Deviation 10.1
|
-72.5 percentage change
Standard Deviation 11.2
|
-93.8 percentage change
Standard Deviation 0.3
|
-21.3 percentage change
Standard Deviation 29.6
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 112
|
-91.7 percentage change
Standard Deviation NA
1 participant analyzed
|
-78.4 percentage change
Standard Deviation 9.9
|
-91.3 percentage change
Standard Deviation 3.5
|
-8.4 percentage change
Standard Deviation 9.2
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 124
|
—
|
-70.1 percentage change
Standard Deviation 15.2
|
-90.1 percentage change
Standard Deviation NA
1 participant analyzed
|
-9.9 percentage change
Standard Deviation 9.1
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 136
|
—
|
—
|
-90.3 percentage change
Standard Deviation NA
1 participant analyzed
|
-3.2 percentage change
Standard Deviation 8.8
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 148
|
—
|
—
|
-89.1 percentage change
Standard Deviation NA
1 participant analyzed
|
3.1 percentage change
Standard Deviation 4.1
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Week 160
|
—
|
—
|
—
|
2.4 percentage change
Standard Deviation 2.9
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
Early Termination
|
—
|
—
|
-91.7 percentage change
Standard Deviation 8.5
|
—
|
—
|
—
|
|
Percent Change in Serum Z-AAT Over Time Through EOS
End of Study
|
-18.0 percentage change
Standard Deviation 2.7
|
-53.8 percentage change
Standard Deviation 6.6
|
-23.4 percentage change
Standard Deviation 0.1
|
9.1 percentage change
Standard Deviation 12.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Fazirsiran participants without fibrosis: Pre-dose, 1 hour, 2 hour, 24 hours post-dose on Day 1 (+/- 1 day). Fazirsiran participants with fibrosis: Pre-dose, 1 hour, 2 hours, 24 hours post-dose on Day 1 and Week 16 (+/- 1 day).Population: PK Population: all Full Analysis Set participants who have at least 1 measurable plasma concentration data; participants with an assessment at given time point. Data not collected Week 16 for participants with no fibrosis per protocol.
Outcome measures
| Measure |
Fazirsiran 25 mg
n=4 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=4 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=3 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=5 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
n=2 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
n=7 Participants
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): ARO-AAT Plasma Concentration Summary for the Double-Blind Phase
Day 1, Pre-Dose
|
0 ng/mL
Geometric Coefficient of Variation 0
|
0 ng/mL
Geometric Coefficient of Variation 0
|
0 ng/mL
Geometric Coefficient of Variation 0
|
0 ng/mL
Geometric Coefficient of Variation 0
|
0 ng/mL
Geometric Coefficient of Variation 0
|
0 ng/mL
Geometric Coefficient of Variation 0
|
|
Pharmacokinetics (PK): ARO-AAT Plasma Concentration Summary for the Double-Blind Phase
Day 1, 1 hour (h)
|
29.9 ng/mL
Geometric Coefficient of Variation 75.6
|
50.6 ng/mL
Geometric Coefficient of Variation 66.8
|
190.0 ng/mL
Geometric Coefficient of Variation 17.9
|
173.0 ng/mL
Geometric Coefficient of Variation 25.7
|
495.0 ng/mL
Geometric Coefficient of Variation 71.8
|
356.0 ng/mL
Geometric Coefficient of Variation 75.9
|
|
Pharmacokinetics (PK): ARO-AAT Plasma Concentration Summary for the Double-Blind Phase
Day 1, 2h
|
35.0 ng/mL
Geometric Coefficient of Variation 83.0
|
60.7 ng/mL
Geometric Coefficient of Variation 72.5
|
208.0 ng/mL
Geometric Coefficient of Variation 11.6
|
199.0 ng/mL
Geometric Coefficient of Variation 32.2
|
537.0 ng/mL
Geometric Coefficient of Variation 81.9
|
471.0 ng/mL
Geometric Coefficient of Variation 56.5
|
|
Pharmacokinetics (PK): ARO-AAT Plasma Concentration Summary for the Double-Blind Phase
Day 1, 24h
|
9.92 ng/mL
Geometric Coefficient of Variation 99.6
|
6.33 ng/mL
Geometric Coefficient of Variation 176.0
|
69.0 ng/mL
Geometric Coefficient of Variation 88.4
|
26.6 ng/mL
Geometric Coefficient of Variation 59.1
|
11.7 ng/mL
Geometric Coefficient of Variation 17100
|
27.7 ng/mL
Geometric Coefficient of Variation 612.0
|
|
Pharmacokinetics (PK): ARO-AAT Plasma Concentration Summary for the Double-Blind Phase
Week 16, Pre-Dose
|
0 ng/mL
Geometric Coefficient of Variation 0
|
0 ng/mL
Geometric Coefficient of Variation 0
|
0 ng/mL
Geometric Coefficient of Variation 0
|
0 ng/mL
Geometric Coefficient of Variation 0
|
0 ng/mL
Geometric Coefficient of Variation 0
|
0 ng/mL
Geometric Coefficient of Variation 0
|
|
Pharmacokinetics (PK): ARO-AAT Plasma Concentration Summary for the Double-Blind Phase
Week 16, 1h
|
—
|
38.1 ng/mL
Geometric Coefficient of Variation 75.3
|
—
|
38.1 ng/mL
Geometric Coefficient of Variation 75.3
|
—
|
396.0 ng/mL
Geometric Coefficient of Variation 64.9
|
|
Pharmacokinetics (PK): ARO-AAT Plasma Concentration Summary for the Double-Blind Phase
Week 16, 2h
|
—
|
45.1 ng/mL
Geometric Coefficient of Variation 70.1
|
—
|
45.1 ng/mL
Geometric Coefficient of Variation 70.1
|
—
|
487.0 ng/mL
Geometric Coefficient of Variation 62.5
|
|
Pharmacokinetics (PK): ARO-AAT Plasma Concentration Summary for the Double-Blind Phase
Week 16, 24h
|
—
|
3.64 ng/mL
Geometric Coefficient of Variation 123.0
|
—
|
3.64 ng/mL
Geometric Coefficient of Variation 123.0
|
—
|
104.0 ng/mL
Geometric Coefficient of Variation 26.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 16, 28, 40, 48, 52, 64, 76, 88, 96, 100, 112, 124, 136, 148 or Early Termination (up to 148 weeks)Population: Safety Analysis Set: all participants who received at least one dose of fazirsiran; participants with an assessment at given time point
PDLB=post-dose liver biopsy
Outcome measures
| Measure |
Fazirsiran 25 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 16
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 28
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 88
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
PDLB at Week 96
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Baseline
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 4
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 40
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
PDLB at Week 48
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 52
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 64
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 76
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 100
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 112
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 124
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 136
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Week 148
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran
Early Termination
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Post-dose at Weeks 48 (+/- 2 weeks) or Week 72 (+/- 4 weeks) or Week 96 (+/- 4 weeks)Population: Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result; participants eligible to meet the defined criteria. (For example, participants with baseline METAVIR fibrosis score 0 are not eligible for improvement; participants with baseline METAVIR fibrosis score 4 are not eligible for worsening.)
The METAVIR scoring system is a system used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy. The stage represents the amount of fibrosis or scarring: 0= no fibrosis; 1=portal fibrosis without septa; 2=portal fibrosis with few septa; 3=numerous septa without cirrhosis; 4=cirrhosis. A higher score indicates a worse condition.
Outcome measures
| Measure |
Fazirsiran 25 mg
n=4 Participants
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=5 Participants
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=7 Participants
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=9 Participants
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg: Participants With No Fibrosis
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
|
Fazirsiran 200 mg: Participants With Fibrosis
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Shifts From Baseline in METAVIR Fibrosis Stage at Post-Dose Biopsy for Participants With Fibrosis
>= 1-point improvement from baseline
|
66.7 percentage of participants
|
40.0 percentage of participants
|
50.0 percentage of participants
|
37.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Shifts From Baseline in METAVIR Fibrosis Stage at Post-Dose Biopsy for Participants With Fibrosis
no change from baseline
|
25.0 percentage of participants
|
60.0 percentage of participants
|
14.3 percentage of participants
|
44.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Shifts From Baseline in METAVIR Fibrosis Stage at Post-Dose Biopsy for Participants With Fibrosis
>= 1-point worsening from baseline
|
25.0 percentage of participants
|
0.0 percentage of participants
|
42.9 percentage of participants
|
22.2 percentage of participants
|
—
|
—
|
Adverse Events
Fazirsiran 25 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Fazirsiran 100 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Fazirsiran 200 mg
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Fazirsiran 25 mg DB/200 mg OL
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Fazirsiran 100 mg DB/200 mg OL
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Fazirsiran 200 mg DB/200 mg OL
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo DB / Fazirsiran 200 mg OL
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fazirsiran 25 mg
n=9 participants at risk
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 participants at risk
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 participants at risk
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 participants at risk
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 25 mg DB/200 mg OL
n=4 participants at risk
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 25 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Fazirsiran 100 mg DB/200 mg OL
n=5 participants at risk
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 100 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Fazirsiran 200 mg DB/200 mg OL
n=5 participants at risk
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 200 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Placebo DB / Fazirsiran 200 mg OL
n=9 participants at risk
Participants with fibrosis at Screening who received double-blind (DB) placebo and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
Other adverse events
| Measure |
Fazirsiran 25 mg
n=9 participants at risk
Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 100 mg
n=8 participants at risk
Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 200 mg
n=9 participants at risk
Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.
Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Placebo
n=14 participants at risk
Participants with no fibrosis: Placebo administered on Day 1 and Week 4.
Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.
|
Fazirsiran 25 mg DB/200 mg OL
n=4 participants at risk
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 25 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Fazirsiran 100 mg DB/200 mg OL
n=5 participants at risk
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 100 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Fazirsiran 200 mg DB/200 mg OL
n=5 participants at risk
Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 200 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
Placebo DB / Fazirsiran 200 mg OL
n=9 participants at risk
Participants with fibrosis at Screening who received double-blind (DB) placebo and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hot flush
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
14.3%
2/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Eye disorders
Vision blurred
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Fatigue
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
14.3%
2/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Flank pain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Pain
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Vascular disorders
Flushing
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
2/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Cardiac disorders
Left atrial enlargement
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Congenital, familial and genetic disorders
Hamartoma
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
21.4%
3/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
40.0%
2/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
14.3%
2/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
2/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Inguinal hernia
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Pancreatic steatosis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Gastrointestinal disorders
Toothache
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Injection site erythema
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
14.3%
2/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Injection site reaction
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Chills
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Injection site pain
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Chest pain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Cyst
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Medical device site haemorrhage
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Medical device site pain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Oedema
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
General disorders
Procedural pain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Immune system disorders
Food allergy
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
2/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
77.8%
7/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
14.3%
2/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Atypical mycobacterial pneumonia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Body tinea
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Candida infection
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Diverticulitis
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
14.3%
2/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
21.4%
3/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Periorbital cellulitis
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Incision site cellulitis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Pertussis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Viral infection
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Concussion
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Injection site erythema
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Injection site induration
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Injection site pain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
2/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
33.3%
3/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
21.4%
3/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Head injury
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Injection site rash
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural pruritus
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Injury, poisoning and procedural complications
Wound
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Forced expiratory volume decreased
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Crystal urine present
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Forced vital capacity decreased
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Lung diffusion test decreased
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Spirometry abnormal
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Investigations
Weight increased
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
2/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
21.4%
3/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Headache
|
44.4%
4/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
28.6%
4/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
40.0%
2/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Sleep apnoea syndrome
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Migraine
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
20.0%
1/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Nervous system disorders
Urinary incontinence
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
21.4%
3/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
22.2%
2/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Breathing-related sleep disorder
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection bacterial
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
21.4%
3/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
2/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
12.5%
1/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin laceration
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
25.0%
1/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Vascular disorders
Poor venous access
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
7.1%
1/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
|
Vascular disorders
Withdrawal hypertension
|
11.1%
1/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/8 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/14 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/4 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/5 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
0.00%
0/9 • Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.
|
Additional Information
Patrick O'Brien, Chief Operating Officer
Arrowhead Pharmaceuticals, Inc.
Phone: 626-304-3400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).
- Publication restrictions are in place
Restriction type: OTHER