Trial Outcomes & Findings for Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA) (NCT NCT04321031)
NCT ID: NCT04321031
Last Updated: 2025-03-21
Results Overview
NASH resolution: disappearance of ballooning (Nonalcoholic Fatty Liver Disease \[NAFLD\] Activity Score \[NAS\] ballooning score=0;0=no ballooning,1=few balloon cells,2=many cells with prominent ballooning; higher scores(HS)=more disease activity \[DA\]),residual/no lobular inflammation(NAS lobular inflammation score 0/1,0=no foci,1= \<2 foci, 2=2-4 foci,3= \>4 foci; HS=more DA),NAS steatosis score 0,1,2,3; 0= \<5% hepatocytes involved (HI),1=5-33% HI ,2= 34-66% HI, 3= \>66% HI; HS=more DA. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale (BKS) compared to baseline (CTB). Improvement in fibrosis by \>=1 stage: decrease of at least 1 stage in BKS CTB. No worsening of NASH: no change/increase in NAS for ballooning, inflammation, steatosis CTB. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
256 participants
Primary outcome timeframe
Week 48
Results posted on
2025-03-21
Participant Flow
A total of 256 participants with biopsy confirmed Non-alcoholic Steatohepatitis (NASH) with fibrosis state (F2-F3) were randomized, of which 255 were treated.
F2: significant stage of fibrosis when scarring had occurred and extended outside liver area and F3: severe stage of fibrosis with spreading and forming bridges with other fibrotic liver areas.
Participant milestones
| Measure |
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
35
|
48
|
42
|
35
|
31
|
30
|
|
Overall Study
COMPLETED
|
32
|
31
|
45
|
35
|
32
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
7
|
3
|
5
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
2
|
2
|
2
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
3
|
1
|
0
|
1
|
|
Overall Study
Non-compliance with study drug
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
Baseline characteristics by cohort
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=30 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.21 Years
STANDARD_DEVIATION 12.00 • n=5 Participants
|
56.54 Years
STANDARD_DEVIATION 11.38 • n=7 Participants
|
56.02 Years
STANDARD_DEVIATION 12.67 • n=5 Participants
|
55.95 Years
STANDARD_DEVIATION 11.32 • n=4 Participants
|
56.60 Years
STANDARD_DEVIATION 10.23 • n=21 Participants
|
59.65 Years
STANDARD_DEVIATION 7.49 • n=8 Participants
|
54.23 Years
STANDARD_DEVIATION 11.32 • n=8 Participants
|
56.28 Years
STANDARD_DEVIATION 11.12 • n=24 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
154 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
101 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Hispanic or Latino
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
71 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
175 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Race · Asian
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
87 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Race · Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Race · White
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
150 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Race · More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: BKS: scaling for fibrosis (0=none,1=perisinusoidal/ periportal,2=perisinusoidal, portal/ periportal,3=bridging,4=cirrhosis; higher scores=more DA). Full analysis set (FAS):all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID).
NASH resolution: disappearance of ballooning (Nonalcoholic Fatty Liver Disease \[NAFLD\] Activity Score \[NAS\] ballooning score=0;0=no ballooning,1=few balloon cells,2=many cells with prominent ballooning; higher scores(HS)=more disease activity \[DA\]),residual/no lobular inflammation(NAS lobular inflammation score 0/1,0=no foci,1= \<2 foci, 2=2-4 foci,3= \>4 foci; HS=more DA),NAS steatosis score 0,1,2,3; 0= \<5% hepatocytes involved (HI),1=5-33% HI ,2= 34-66% HI, 3= \>66% HI; HS=more DA. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale (BKS) compared to baseline (CTB). Improvement in fibrosis by \>=1 stage: decrease of at least 1 stage in BKS CTB. No worsening of NASH: no change/increase in NAS for ballooning, inflammation, steatosis CTB. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Proportion of Participants Achieving Resolution of NASH Without Worsening/Improvement of Fibrosis by >=1 Stage Without Worsening of NASH/Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48:Bayesian Dose Response Model (BDRM)
|
0.38 Proportion of participants
Interval 0.26 to 0.5
|
0.45 Proportion of participants
Interval 0.38 to 0.53
|
0.48 Proportion of participants
Interval 0.42 to 0.55
|
0.50 Proportion of participants
Interval 0.43 to 0.57
|
0.51 Proportion of participants
Interval 0.43 to 0.59
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 48Population: BKS: scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/periportal, 3= bridging, 4= cirrhosis; higher scores= more disease activity). Logistic Regression model included treatment and baseline F2/F3 as factors. Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for the primary endpoint.
Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2, or 3, where 0= \<5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in BKS compared to baseline. Improvement in fibrosis by \>=1 stage: decrease of at least 1 stage in BKS compared to baseline. No worsening of NASH: no change or increase in NAS for ballooning, inflammation, steatosis compared to baseline.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=35 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=30 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving Resolution of NASH Without Worsening or Improvement in Fibrosis by >= 1 Stage Without Worsening of NASH or Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48: Logistic Regression Model
|
13 Participants
|
16 Participants
Interval 0.61 to 3.05
|
25 Participants
Interval 0.83 to 3.72
|
21 Participants
Interval 0.74 to 3.48
|
23 Participants
Interval 1.35 to 7.04
|
14 Participants
Interval 0.58 to 3.08
|
19 Participants
Interval 1.19 to 6.56
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full analysis set: all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID). Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Magnetic resonance imaging proton density fat fraction (MRI-PDFF) is an established method that enables quantification of fat content in the liver.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=14 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=21 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=18 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=11 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Fat at Week 48: Bayesian Dose Response Model
|
-10.79 Percent change
Interval -38.3 to 18.99
|
-36.76 Percent change
Interval -52.57 to -20.15
|
-46.20 Percent change
Interval -59.64 to -32.82
|
-51.33 Percent change
Interval -66.78 to -36.59
|
-55.53 Percent change
Interval -77.23 to -37.64
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Full analysis set: all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
MRI-PDFF is an established method that enables quantification of fat content in the liver.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=12 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=18 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=12 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=11 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=8 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=8 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Fat at Week 48: Pairwise Comparisons With Analysis of Covariance (ANCOVA)
|
1.41 Percent change
Standard Error 22.11
|
-41.00 Percent change
Standard Error 18.89
|
-42.53 Percent change
Standard Error 15.66
|
-58.77 Percent change
Standard Error 19.44
|
-67.76 Percent change
Standard Error 19.93
|
-49.76 Percent change
Standard Error 23.70
|
-68.83 Percent change
Standard Error 23.72
|
SECONDARY outcome
Timeframe: Week 48Population: FAS included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID).
Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2 or 3, where 0= \<5% HI, 1= 5-33% HI, 2= 34-66% HI, 3= \>66% HI; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in BKS compared to baseline. BKS: scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores= more disease activity). BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Proportion of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
|
0.11 Proportion of participants
Interval 0.04 to 0.2
|
0.32 Proportion of participants
Interval 0.23 to 0.4
|
0.37 Proportion of participants
Interval 0.31 to 0.44
|
0.40 Proportion of participants
Interval 0.33 to 0.47
|
0.41 Proportion of participants
Interval 0.34 to 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint.
Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2 or 3, where 0= \<5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more disease activity). Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=35 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=30 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
|
3 Participants
|
11 Participants
|
22 Participants
|
13 Participants
|
22 Participants
|
13 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID).
Improvement in fibrosis by \>=1 stage: decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. No worsening of fibrosis: no change or decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more disease activity). BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Proportion of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
|
0.33 Proportion of participants
Interval 0.22 to 0.45
|
0.28 Proportion of participants
Interval 0.21 to 0.35
|
0.25 Proportion of participants
Interval 0.2 to 0.31
|
0.24 Proportion of participants
Interval 0.18 to 0.3
|
0.22 Proportion of participants
Interval 0.14 to 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint.
Improvement in fibrosis by \>=1 stage: decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more DA). Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=35 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=30 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
|
12 Participants
|
10 Participants
|
10 Participants
|
14 Participants
|
13 Participants
|
4 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID).
Improvement in fibrosis by \>=2 stage: decrease of at least 2 points in total NAS compared to baseline, without progression of fibrosis. No worsening of NASH: no change or no increase in NAS for ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), steatosis (NAS steatosis score 0, 1, 2, or 3, where 0= \<5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores=more disease activity) compared to baseline. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Proportion of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
|
0.05 Proportion of participants
Interval 0.01 to 0.1
|
0.08 Proportion of participants
Interval 0.04 to 0.11
|
0.09 Proportion of participants
Interval 0.05 to 0.12
|
0.09 Proportion of participants
Interval 0.06 to 0.14
|
0.10 Proportion of participants
Interval 0.06 to 0.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint.
Improvement in fibrosis by \>=2 stage: decrease of at least 2 points in total NAS compared to baseline, without progression of fibrosis. No worsening of NASH: no change or no increase in NAS for ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), steatosis (NAS steatosis score 0, 1, 2 or 3, where 0= \<5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores= more disease activity) compared to baseline. Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=35 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=30 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
|
1 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID).
Improvement of \>=2 points in Total NAS: decrease of at least 2 points in Total NAS compared to baseline, without progression of fibrosis. Total NAS ranged 0 to 8, higher scores= more disease activity and calculated as sum of scores of steatosis (0= \<5% hepatocytes involved, 1=5-33% hepatocytes involved, 2=34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores= more disease activity), lobular inflammation (0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), ballooning (0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity). If sub-scale scores non evaluable or missing, total score was derived as missing. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Proportion of Participants Achieving Improvement of >=2 Points in Total NAS, Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model
|
0.24 Proportion of participants
Interval 0.13 to 0.37
|
0.42 Proportion of participants
Interval 0.33 to 0.5
|
0.47 Proportion of participants
Interval 0.4 to 0.54
|
0.49 Proportion of participants
Interval 0.42 to 0.57
|
0.51 Proportion of participants
Interval 0.43 to 0.59
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint.
Improvement of \>=2 points in Total NAS: decrease of at least 2 points in Total NAS compared to baseline, without progression of fibrosis. Total NAS ranged from 0 to 8, higher scores= more DA and calculated as sum of scores of steatosis (0= \<5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores= more DA), lobular inflammation (0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more DA), ballooning (0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more DA). If any of the sub-scale scores were non evaluable/missing, then the total score was derived as missing. Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=35 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=30 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving Improvement of >=2 Points in Total NAS Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model
|
8 Participants
|
13 Participants
|
28 Participants
|
21 Participants
|
25 Participants
|
12 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)Population: Safety population included all participants who took at least 1 dose of investigational product.
An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Serious adverse events (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening (risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. AEs included both serious and all non-serious AEs. TEAEs were defined as newly occurring or worsening AE after the first dose of study drug.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=35 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=30 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
26 Participants
|
25 Participants
|
38 Participants
|
30 Participants
|
25 Participants
|
26 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)Population: Safety population included all participants who took at least 1 dose of investigational product. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Laboratory abnormalities included: Hematology (Hemoglobin \[hgb\], hematocrit, erythrocytes \[ery\]: \<0.8\*lower limit of normal \[LLN\]; reticulocytes, reticulocytes/ery: \<0.5\*LLN, \>1.5\*upper LN \[ULN\]; ery mean corpuscular volume \[EMC\], EMC hgb: \<0.9\*LLN, \>1.1\*ULN; platelet: \>1.75 ULN; lymphocytes, neutrophils, basophils, eosinophils: \<0.8\* LLN, \>1.2\*ULN; monocytes: \>1.2\*ULN; activated partial thromboplastin time, prothrombin time: \>1.1\*ULN); Clinical chemistry (Total/direct bilirubin, glucose:\>1.5\*ULN; aspartate aminotransferase \[AT\], alanine AT, gamma glutamyl transferase: \>3.0\*ULN; HDL cholesterol: \<0.8\*LLN; urea nitrogen, creatinine, triglyceride, cholesterol, hgb A1C: \>1.3\*ULN; urate: \>1.2\*ULN; potassium: \<0.9\*LLN, \>1.1\*ULN; sodium: \<0.95\*LLN; calcium, bicarbonate: \<0.9\*LLN; creatine kinase: \>2.0\*ULN); Urinalysis (glucose, protein, hgb, ketones, nitrite, leukocyte esterase, urobilinogen, bilirubin: \>=1; ery, leukocytes: \>=20; granular, hyaline casts: \>1).
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=34 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=35 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=30 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
31 Participants
|
32 Participants
|
46 Participants
|
39 Participants
|
34 Participants
|
27 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks)Population: Safety population included all participants who took at least 1 dose of investigational product. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Number of participants with clinically significant vital signs were reported in this outcome measure. Vital signs included blood pressure, and heart rate. Clinical significance in vital signs abnormalities was judged by investigator.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=34 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=35 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=30 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks)Population: Safety population included all participants who took at least 1 dose of investigational product. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Number of participants with clinically significant ECG abnormalities were reported in this outcome measure. ECG parameters included heart rate, PR interval, QRS interval and QTcF interval.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=32 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=47 Participants
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=39 Participants
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=35 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=28 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=28 Participants
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECG) Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
DGAT2i/PF-06865571 25 mg BID
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
DGAT2i/PF-06865571 75 mg BID
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
DGAT2i/PF-06865571 150 mg BID
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
DGAT2i/PF-06865571 300 mg BID
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=34 participants at risk
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 participants at risk
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 participants at risk
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 participants at risk
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID
n=35 participants at risk
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 participants at risk
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=30 participants at risk
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.3%
1/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.3%
1/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
General disorders
Pyrexia
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Subcapsular hepatic hematoma
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Infections and infestations
Appendicitis
|
2.9%
1/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Infections and infestations
COVID-19
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucoepidermoid carcinoma
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.4%
1/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
Other adverse events
| Measure |
Placebo
n=34 participants at risk
Participants were randomized to receive 2 tablets of diacylglycerol acyltransferase 2 inhibitor (PF-06865571/DGAT2i) matching placebo and 1 tablet of acetyl-CoA carboxylase inhibitor (PF-05221304/ACCi) matching placebo twice a day (BID) for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 25 mg BID
n=35 participants at risk
Participants were randomized to receive 1 tablet of DGAT2i 25 milligrams (mg) along with 1 tablet of DGAT2i and ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 75 mg BID
n=48 participants at risk
Participants were randomized to receive 1 tablet of DGAT2i 25 mg, 1 tablet of DGAT2i 50 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID
n=42 participants at risk
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID
n=35 participants at risk
Participants were randomized to receive 1 tablet of DGAT2i matching placebo, 1 tablet of DGAT2i 150 mg and 1 tablet of ACCi 5 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID
n=31 participants at risk
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi matching placebo BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID
n=30 participants at risk
Participants were randomized to receive 2 tablets of DGAT2i 150 mg and 1 tablet of ACCi 10 mg BID for 48 weeks by oral administration. Participants were followed up to 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
11.4%
4/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.2%
3/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
4.8%
2/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.5%
2/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.8%
3/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
7.1%
3/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
8.6%
3/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.3%
1/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
8.6%
3/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
10.4%
5/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
7.1%
3/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
8.6%
3/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
9.7%
3/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.7%
2/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
10.4%
5/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.4%
1/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.7%
2/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
8.3%
4/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
4.8%
2/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.7%
2/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
General disorders
Fatigue
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
8.3%
4/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.4%
1/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
9.7%
3/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.3%
1/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
General disorders
Puncture site pain
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
General disorders
Pyrexia
|
5.9%
2/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.2%
3/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.4%
1/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.3%
1/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Infections and infestations
COVID-19
|
5.9%
2/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
8.3%
4/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
7.1%
3/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
9.7%
3/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.7%
2/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Infections and infestations
Gastroenteritis
|
2.9%
1/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.4%
1/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
4/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
8.3%
4/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
4.8%
2/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
9.7%
3/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
9.5%
4/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
8.6%
3/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.3%
1/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
4.2%
2/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
11.4%
4/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.7%
2/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
7.1%
3/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.7%
2/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.4%
1/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.4%
1/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
13.3%
4/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
2/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
4.8%
2/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
9.7%
3/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
11.8%
4/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
17.1%
6/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
10.4%
5/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
7.1%
3/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.5%
2/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.7%
2/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
2/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
4.2%
2/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
4.8%
2/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
8.6%
3/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
9.7%
3/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.7%
2/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.2%
3/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
4.8%
2/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
9.7%
3/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.1%
1/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.4%
1/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.7%
2/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.9%
1/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.3%
1/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
4.2%
2/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
7.1%
3/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
8.6%
3/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
4.2%
2/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.4%
1/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.5%
2/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Nervous system disorders
Headache
|
11.8%
4/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
10.4%
5/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.4%
1/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
11.4%
4/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.3%
1/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
2/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
2.9%
1/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.5%
2/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.2%
3/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.4%
1/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
3.2%
1/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
2.9%
1/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
6.5%
2/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/34 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/48 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/42 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
5.7%
2/35 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/31 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
0.00%
0/30 • From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who took at least 1 dose of investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER