Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis (NCT NCT06073119)
NCT ID: NCT06073119
Last Updated: 2025-11-10
Results Overview
PASI is linear combination of percent of surface area of skin that is affected and severity of erythema(E),induration(i),desquamation(D) over 4 body regions: head(h),trunk(t),upper extremities(u),lower extremities(l). The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range:0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax":0=no involvement,1=\<10% to 6=90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. PASI score range:0 (no disease) to 72 (maximal disease);higher scores: greater psoriasis severity. Percentage of participants with PASI75 at Week 12 is presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
221 participants
Primary outcome timeframe
Baseline (Day 1) and Week 12
Results posted on
2025-11-10
Participant Flow
The study was conducted at 51 centers in 17 countries. A total of 292 participants were screened from 26 October 2023 to 24 July 2024, of which 71 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.
221 participants were randomized in 2 different strata: naïve targeted immunotherapy population (NTIP) and experienced targeted immunotherapy population (ETIP). 147 participants were randomized into NTIP in 1:1:1:1:1:1 ratio to receive either placebo or SAR441566 at 200 mg BID, 100 mg BID, 200 mg QD, 100 mg QD or 50 mg QD. 74 participants were randomized into ETIP in 2:2:2:1 ratio to receive either placebo or SAR441566 at 200 mg BID, 200 mg QD, 100 mg QD. ETIP was used for exploratory analysis.
Participant milestones
| Measure |
Placebo
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg BID
Participants received 200 milligrams (mg) twice a day (BID) of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg BID
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg QD
Participants received 200 mg once a day (QD) of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg QD
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 50 mg QD
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
47
|
24
|
46
|
45
|
24
|
|
Overall Study
COMPLETED
|
27
|
36
|
20
|
41
|
39
|
23
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
4
|
5
|
6
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg BID
Participants received 200 milligrams (mg) twice a day (BID) of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg BID
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg QD
Participants received 200 mg once a day (QD) of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg QD
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 50 mg QD
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
0
|
0
|
1
|
0
|
|
Overall Study
Non-compliance with study schedule
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
3
|
5
|
3
|
1
|
|
Overall Study
Other
|
2
|
4
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=35 Participants
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg BID
n=47 Participants
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg BID
n=24 Participants
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg QD
n=46 Participants
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg QD
n=45 Participants
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 50 mg QD
n=24 Participants
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 13.7 • n=20 Participants
|
45.5 years
STANDARD_DEVIATION 11.0 • n=40 Participants
|
45.4 years
STANDARD_DEVIATION 13.9 • n=28 Participants
|
46.8 years
STANDARD_DEVIATION 12.9 • n=46 Participants
|
38.4 years
STANDARD_DEVIATION 13.2 • n=34 Participants
|
44.3 years
STANDARD_DEVIATION 13.2 • n=22 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
12 Participants
n=28 Participants
|
13 Participants
n=46 Participants
|
13 Participants
n=34 Participants
|
75 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
33 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
34 Participants
n=28 Participants
|
32 Participants
n=46 Participants
|
11 Participants
n=34 Participants
|
146 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
7 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
8 Participants
n=28 Participants
|
4 Participants
n=46 Participants
|
2 Participants
n=34 Participants
|
32 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=28 Participants
|
2 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
3 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=46 Participants
|
1 Participants
n=34 Participants
|
6 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
38 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
37 Participants
n=28 Participants
|
37 Participants
n=46 Participants
|
21 Participants
n=34 Participants
|
176 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
3 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The NTIP included all randomized participants who never received targeted immunotherapy for psoriasis.
PASI is linear combination of percent of surface area of skin that is affected and severity of erythema(E),induration(i),desquamation(D) over 4 body regions: head(h),trunk(t),upper extremities(u),lower extremities(l). The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range:0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax":0=no involvement,1=\<10% to 6=90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. PASI score range:0 (no disease) to 72 (maximal disease);higher scores: greater psoriasis severity. Percentage of participants with PASI75 at Week 12 is presented.
Outcome measures
| Measure |
Placebo
n=25 Participants
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg BID
n=25 Participants
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg BID
n=24 Participants
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg QD
n=24 Participants
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg QD
n=25 Participants
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 50 mg QD
n=24 Participants
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a 75% or Greater Psoriasis Area and Severity Index (PASI) Score Reduction From Baseline (PASI75) at Week 12
|
20.0 percentage of participants
|
44.0 percentage of participants
|
50.0 percentage of participants
|
58.3 percentage of participants
|
28.0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: The NTIP included all randomized participants who never received targeted immunotherapy for psoriasis.
PASI is linear combination of percent of surface area of skin that is affected and severity of E, i, D over 4 body regions: h, t, u, l. The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range: 0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax": 0= no involvement,1= \<10% to 6 =90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. The PASI score ranges from 0 (no disease) to 72 (maximal disease); higher scores indicate greater psoriasis severity. Baseline was defined as last available value before the first dose of study treatment.
Outcome measures
| Measure |
Placebo
n=25 Participants
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg BID
n=25 Participants
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg BID
n=24 Participants
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg QD
n=24 Participants
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg QD
n=25 Participants
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 50 mg QD
n=24 Participants
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Psoriasis Area and Severity Index to Week 12
|
-40.65 percent change
Interval -52.98 to -28.33
|
-63.42 percent change
Interval -75.73 to -51.11
|
-60.56 percent change
Interval -73.12 to -48.01
|
-65.18 percent change
Interval -77.74 to -52.62
|
-60.84 percent change
Interval -73.14 to -48.54
|
-65.85 percent change
Interval -78.4 to -53.3
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The NTIP included all randomized participants who never received targeted immunotherapy for psoriasis.
sPGA is 5-point score based on average thickness,erythema,and scaling of all psoriatic lesions.Score ranges:E:0(normal) to 4(bright to deep red coloration of lesions); i (plaque elevation):0(none) to 4(severe thickening with hard edges; D:0(no scaling) to 3(moderate scaling).Overall scoring: average of E,i,D;range:0(clear)= 0 for all 3 symptoms; 1(almost clear)=mean \>0, \<1.5, normal to pink coloration, just detectable(possible slight elevation),no to minimal focal scaling; 2(mild)= mean \>= 1.5, \<2.5, pink to light red coloration, mild thickening, predominantly fine scaling; 3(moderate)= mean \>=2.5,\<3.5, dull to bright red coloration, clearly distinguishable to moderate thickening, moderate scaling; 4(severe)= mean \>=3.5,bright to deep dark red coloration,severe thickening with hard edges,severe coarse scaling covering almost all or all lesions.Lower score:less body coverage,with 0:complete clearance and 1:minimal disease. Total participants who received score of 0 and 1 are reported.
Outcome measures
| Measure |
Placebo
n=25 Participants
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg BID
n=25 Participants
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg BID
n=24 Participants
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg QD
n=24 Participants
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg QD
n=25 Participants
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 50 mg QD
n=24 Participants
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Static Psoriasis Global Assessment (sPGA) Score 0 (Complete Clearance) or 1 (Minimal Disease) at Week 12
|
24.0 percentage of participants
|
36.0 percentage of participants
|
54.2 percentage of participants
|
58.3 percentage of participants
|
36.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 daysPopulation: The safety population included all randomized participants who took at least 1 dose of study treatment, regardless of the amount of treatment administered.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were AEs that developed, worsened or became serious during the TE period. An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg BID
n=47 Participants
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg BID
n=24 Participants
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg QD
n=46 Participants
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg QD
n=45 Participants
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 50 mg QD
n=24 Participants
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Study Treatment Discontinuation and Study Withdrawals Due to TEAEs
Any TEAE
|
12 Participants
|
27 Participants
|
9 Participants
|
26 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Study Treatment Discontinuation and Study Withdrawals Due to TEAEs
Any TEAE leading to study treatment discontinuation
|
1 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Study Treatment Discontinuation and Study Withdrawals Due to TEAEs
Any TESAE
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Study Treatment Discontinuation and Study Withdrawals Due to TEAEs
Any TEAESI
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Study Treatment Discontinuation and Study Withdrawals Due to TEAEs
Any TEAE leading to study treatment withdrawal
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 hour pre-dose on Weeks 2, 4, 8 and 12Population: The pharmacokinetic (PK) population included all participants from the safety population with at least 1 post-baseline PK result with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported.
Blood samples were collected at indicated timepoints for the assessment of pre-dose plasma concentration of SAR441566.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg BID
n=20 Participants
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg BID
n=38 Participants
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg QD
n=38 Participants
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg QD
n=23 Participants
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 50 mg QD
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Pre-Dose Plasma Concentration of SAR441566
Week 2
|
289.714 nanogram per milliliter (ng/mL)
Standard Deviation 178.652
|
115.745 nanogram per milliliter (ng/mL)
Standard Deviation 79.341
|
71.126 nanogram per milliliter (ng/mL)
Standard Deviation 33.287
|
32.581 nanogram per milliliter (ng/mL)
Standard Deviation 18.090
|
16.685 nanogram per milliliter (ng/mL)
Standard Deviation 9.880
|
—
|
|
Pre-Dose Plasma Concentration of SAR441566
Week 4
|
294.928 nanogram per milliliter (ng/mL)
Standard Deviation 193.309
|
110.083 nanogram per milliliter (ng/mL)
Standard Deviation 72.664
|
74.071 nanogram per milliliter (ng/mL)
Standard Deviation 41.391
|
31.011 nanogram per milliliter (ng/mL)
Standard Deviation 18.041
|
17.089 nanogram per milliliter (ng/mL)
Standard Deviation 10.061
|
—
|
|
Pre-Dose Plasma Concentration of SAR441566
Week 8
|
285.981 nanogram per milliliter (ng/mL)
Standard Deviation 200.600
|
101.216 nanogram per milliliter (ng/mL)
Standard Deviation 63.100
|
66.287 nanogram per milliliter (ng/mL)
Standard Deviation 50.241
|
34.729 nanogram per milliliter (ng/mL)
Standard Deviation 21.556
|
14.566 nanogram per milliliter (ng/mL)
Standard Deviation 14.117
|
—
|
|
Pre-Dose Plasma Concentration of SAR441566
Week 12
|
242.188 nanogram per milliliter (ng/mL)
Standard Deviation 151.416
|
86.317 nanogram per milliliter (ng/mL)
Standard Deviation 53.575
|
56.216 nanogram per milliliter (ng/mL)
Standard Deviation 34.269
|
30.711 nanogram per milliliter (ng/mL)
Standard Deviation 22.277
|
14.650 nanogram per milliliter (ng/mL)
Standard Deviation 10.029
|
—
|
SECONDARY outcome
Timeframe: 2.5 to 3.5 hours post-dose on Day 1, Weeks 2, 4, 8 and 12Population: The PK population included all participants from the safety population with at least 1 post-baseline PK result with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported.
Blood samples were collected at indicated timepoints for the assessment of post-dose plasma concentration of SAR441566.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg BID
n=22 Participants
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg BID
n=42 Participants
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg QD
n=43 Participants
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg QD
n=24 Participants
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 50 mg QD
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Post-Dose Plasma Concentration of SAR441566
Week 8
|
428.111 ng/mL
Standard Deviation 291.601
|
183.570 ng/mL
Standard Deviation 101.811
|
222.750 ng/mL
Standard Deviation 168.237
|
100.190 ng/mL
Standard Deviation 59.421
|
51.175 ng/mL
Standard Deviation 35.799
|
—
|
|
Post-Dose Plasma Concentration of SAR441566
Week 12
|
401.897 ng/mL
Standard Deviation 191.133
|
150.990 ng/mL
Standard Deviation 80.672
|
153.229 ng/mL
Standard Deviation 86.896
|
86.200 ng/mL
Standard Deviation 41.862
|
42.877 ng/mL
Standard Deviation 24.508
|
—
|
|
Post-Dose Plasma Concentration of SAR441566
Week 4
|
432.998 ng/mL
Standard Deviation 224.552
|
176.800 ng/mL
Standard Deviation 87.429
|
184.854 ng/mL
Standard Deviation 91.237
|
89.428 ng/mL
Standard Deviation 45.908
|
45.145 ng/mL
Standard Deviation 28.222
|
—
|
|
Post-Dose Plasma Concentration of SAR441566
Day 1
|
135.396 ng/mL
Standard Deviation 77.175
|
58.449 ng/mL
Standard Deviation 25.096
|
132.462 ng/mL
Standard Deviation 71.387
|
59.010 ng/mL
Standard Deviation 34.099
|
33.008 ng/mL
Standard Deviation 16.583
|
—
|
|
Post-Dose Plasma Concentration of SAR441566
Week 2
|
438.750 ng/mL
Standard Deviation 243.198
|
151.108 ng/mL
Standard Deviation 72.612
|
158.463 ng/mL
Standard Deviation 88.156
|
115.275 ng/mL
Standard Deviation 49.937
|
56.667 ng/mL
Standard Deviation 16.388
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
SAR441566 200 mg BID
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
SAR441566 100 mg BID
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SAR441566 200 mg QD
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
SAR441566 100 mg QD
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
SAR441566 50 mg QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=35 participants at risk
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg BID
n=47 participants at risk
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg BID
n=24 participants at risk
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg QD
n=46 participants at risk
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg QD
n=45 participants at risk
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 50 mg QD
n=24 participants at risk
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Pancreatic Neoplasm
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Fracture Of Penis
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
Other adverse events
| Measure |
Placebo
n=35 participants at risk
Participants received placebo matched to SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg BID
n=47 participants at risk
Participants received 200 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg BID
n=24 participants at risk
Participants received 100 mg BID of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 200 mg QD
n=46 participants at risk
Participants received 200 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 100 mg QD
n=45 participants at risk
Participants received 100 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
SAR441566 50 mg QD
n=24 participants at risk
Participants received 50 mg QD of SAR441566 orally from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.7%
2/35 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/47 • Number of events 3 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
6.5%
3/46 • Number of events 3 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
6.4%
3/47 • Number of events 3 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.7%
2/35 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
6.4%
3/47 • Number of events 4 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
6.4%
3/47 • Number of events 3 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Infections and infestations
Furuncle
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Infections and infestations
Influenza
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Infections and infestations
Localised Infection
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
10.6%
5/47 • Number of events 6 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
10.6%
5/47 • Number of events 5 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
12.5%
3/24 • Number of events 3 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Infections and infestations
Viral Labyrinthitis
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic Keratosis
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Blood and lymphatic system disorders
Idiopathic Neutropenia
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Metabolism and nutrition disorders
Diabetic Metabolic Decompensation
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Psychiatric disorders
Tension
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Faeces Soft
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/47 • Number of events 3 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia Areata
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Renal and urinary disorders
Renal Pain
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
General disorders
Fatigue
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
General disorders
Malaise
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
General disorders
Pyrexia
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Investigations
Bilirubin Conjugated Increased
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.3%
2/46 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Investigations
Electrocardiogram Qt Interval Abnormal
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/47 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
|
Social circumstances
Pregnancy Of Partner
|
0.00%
0/35 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/46 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/45 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
0.00%
0/24 • Adverse events were collected from first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days. All-cause mortality (deaths) were collected from screening (Week -4) up to end of follow-up, 412 days.
Analysis was performed on the safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610 ext 6#
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER