Trial Outcomes & Findings for Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT05938920)
NCT ID: NCT05938920
Last Updated: 2025-12-11
Results Overview
TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT. CTCAE=Common Terminology Criteria for Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)
Results posted on
2025-12-11
Participant Flow
Participant milestones
| Measure |
INS018_055 30 mg QD
Group 1: INS018\_055 once daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 30 mg BID
Group 2: INS018\_055 twice daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 60 mg QD
Group 3: INS018\_055 once daily up to 12 weeks, high dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
Placebo
Group 4: Placebo once or twice daily up to 12 weeks INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
18
|
17
|
|
Overall Study
COMPLETED
|
16
|
14
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
5
|
1
|
Reasons for withdrawal
| Measure |
INS018_055 30 mg QD
Group 1: INS018\_055 once daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 30 mg BID
Group 2: INS018\_055 twice daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 60 mg QD
Group 3: INS018\_055 once daily up to 12 weeks, high dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
Placebo
Group 4: Placebo once or twice daily up to 12 weeks INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
2
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant Asked to Withdraw from the Trial
|
1
|
0
|
0
|
0
|
|
Overall Study
Participant Withdrew from Treatment and Refused to do Visit 7 Follow Up Visit
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant Refused to Come In
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Baseline characteristics by cohort
| Measure |
INS018_055 30 mg QD
n=18 Participants
Group 1: INS018\_055 once daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 30 mg BID
n=18 Participants
Group 2: INS018\_055 twice daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 60 mg QD
n=18 Participants
Group 3: INS018\_055 once daily up to 12 weeks, high dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
Placebo
n=17 Participants
Group 4: Placebo once or twice daily up to 12 weeks INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 6.99 • n=237 Participants
|
67.2 years
STANDARD_DEVIATION 7.77 • n=243 Participants
|
65.7 years
STANDARD_DEVIATION 6.82 • n=480 Participants
|
68.3 years
STANDARD_DEVIATION 5.28 • n=639 Participants
|
66.7 years
STANDARD_DEVIATION 6.73 • n=277 Participants
|
|
Age, Customized
≤ 65 years
|
9 Participants
n=237 Participants
|
7 Participants
n=243 Participants
|
7 Participants
n=480 Participants
|
4 Participants
n=639 Participants
|
27 Participants
n=277 Participants
|
|
Age, Customized
> 65 to ≤ 75 years
|
7 Participants
n=237 Participants
|
9 Participants
n=243 Participants
|
10 Participants
n=480 Participants
|
13 Participants
n=639 Participants
|
39 Participants
n=277 Participants
|
|
Age, Customized
>75 years
|
2 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
1 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
5 Participants
n=277 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=237 Participants
|
3 Participants
n=243 Participants
|
2 Participants
n=480 Participants
|
2 Participants
n=639 Participants
|
7 Participants
n=277 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=237 Participants
|
15 Participants
n=243 Participants
|
16 Participants
n=480 Participants
|
15 Participants
n=639 Participants
|
64 Participants
n=277 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=237 Participants
|
18 Participants
n=243 Participants
|
18 Participants
n=480 Participants
|
17 Participants
n=639 Participants
|
71 Participants
n=277 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=237 Participants
|
18 Participants
n=243 Participants
|
18 Participants
n=480 Participants
|
17 Participants
n=639 Participants
|
71 Participants
n=277 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
|
Height at Baseline
|
167.77 centimeters (cm)
STANDARD_DEVIATION 5.549 • n=237 Participants
|
165.78 centimeters (cm)
STANDARD_DEVIATION 7.869 • n=243 Participants
|
166.29 centimeters (cm)
STANDARD_DEVIATION 6.470 • n=480 Participants
|
164.50 centimeters (cm)
STANDARD_DEVIATION 7.874 • n=639 Participants
|
166.11 centimeters (cm)
STANDARD_DEVIATION 6.944 • n=277 Participants
|
|
Weight at Baseline
|
72.27 kilograms (kg)
STANDARD_DEVIATION 7.395 • n=237 Participants
|
67.36 kilograms (kg)
STANDARD_DEVIATION 12.141 • n=243 Participants
|
73.32 kilograms (kg)
STANDARD_DEVIATION 13.547 • n=480 Participants
|
67.69 kilograms (kg)
STANDARD_DEVIATION 12.117 • n=639 Participants
|
70.20 kilograms (kg)
STANDARD_DEVIATION 11.593 • n=277 Participants
|
|
Body Mass Index at Baseline
|
25.66 kg/m2
STANDARD_DEVIATION 2.080 • n=237 Participants
|
24.41 kg/m2
STANDARD_DEVIATION 3.399 • n=243 Participants
|
26.41 kg/m2
STANDARD_DEVIATION 4.128 • n=480 Participants
|
24.96 kg/m2
STANDARD_DEVIATION 3.733 • n=639 Participants
|
25.36 kg/m2
STANDARD_DEVIATION 3.429 • n=277 Participants
|
|
Forced vital capacity (FVC) at Baseline
|
2.6961 liters (L)
STANDARD_DEVIATION 0.44422 • n=237 Participants
|
2.6170 liters (L)
STANDARD_DEVIATION 0.66740 • n=243 Participants
|
2.7616 liters (L)
STANDARD_DEVIATION 0.68415 • n=480 Participants
|
2.2456 liters (L)
STANDARD_DEVIATION 0.47359 • n=639 Participants
|
2.5848 liters (L)
STANDARD_DEVIATION 0.60040 • n=277 Participants
|
|
Diffusion capacity of the lung for carbon monoxide (DLCO) (actual) at Baseline
|
3.7832 mmol/min/kPa
STANDARD_DEVIATION 1.03476 • n=237 Participants
|
3.4291 mmol/min/kPa
STANDARD_DEVIATION 0.93188 • n=243 Participants
|
3.7561 mmol/min/kPa
STANDARD_DEVIATION 1.25320 • n=480 Participants
|
3.6085 mmol/min/kPa
STANDARD_DEVIATION 1.08683 • n=639 Participants
|
3.6447 mmol/min/kPa
STANDARD_DEVIATION 1.06898 • n=277 Participants
|
|
Diffusion capacity of the lung for carbon monoxide (DLCO) (% predicted) at Baseline
|
47.6952 percentage
STANDARD_DEVIATION 12.41070 • n=237 Participants
|
45.1767 percentage
STANDARD_DEVIATION 10.55849 • n=243 Participants
|
48.9831 percentage
STANDARD_DEVIATION 16.53697 • n=480 Participants
|
49.1347 percentage
STANDARD_DEVIATION 15.72199 • n=639 Participants
|
47.7279 percentage
STANDARD_DEVIATION 13.78235 • n=277 Participants
|
|
6-minute walk distance (6-MWD) test (in meters) at Baseline
|
420.81 meters (m)
STANDARD_DEVIATION 122.020 • n=237 Participants
|
387.26 meters (m)
STANDARD_DEVIATION 80.066 • n=243 Participants
|
378.04 meters (m)
STANDARD_DEVIATION 76.252 • n=480 Participants
|
393.21 meters (m)
STANDARD_DEVIATION 73.022 • n=639 Participants
|
394.85 meters (m)
STANDARD_DEVIATION 89.806 • n=277 Participants
|
|
Leicester Cough Questionnaire (LCQ) total score at Baseline
|
17.1290 scores on a scale
STANDARD_DEVIATION 3.08860 • n=237 Participants
|
16.1677 scores on a scale
STANDARD_DEVIATION 3.51858 • n=243 Participants
|
15.7431 scores on a scale
STANDARD_DEVIATION 3.70099 • n=480 Participants
|
16.4370 scores on a scale
STANDARD_DEVIATION 3.05011 • n=639 Participants
|
16.3682 scores on a scale
STANDARD_DEVIATION 3.32222 • n=277 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)Population: Safety Population: The safety population included all participants who received at least 1 dose of study treatment.
TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT. CTCAE=Common Terminology Criteria for Adverse Events
Outcome measures
| Measure |
INS018_055 30 mg QD
n=18 Participants
Group 1: INS018\_055 once daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 30 mg BID
n=18 Participants
Group 2: INS018\_055 twice daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 60 mg QD
n=18 Participants
Group 3: INS018\_055 once daily up to 12 weeks, high dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
Placebo
n=17 Participants
Group 4: Placebo once or twice daily up to 12 weeks
Placebo: Pharmaceutical formulation: Capsules
Mode of Administration: Oral
|
|---|---|---|---|---|
|
Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)
Any TEAE
|
13 Participants
|
15 Participants
|
15 Participants
|
12 Participants
|
|
Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)
TEAE with CTCAE grade ≥3
|
3 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
|
Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)
TEAE Leading to discontinuation of treatment
|
1 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)
TEAE Leading to death
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0/Visit 2 up to Week 12Population: Intent-to-treat Population: The ITT population included any randomized participant. The ITT Population was used for summary of demographic and baseline characteristics, and it was used for analysis of secondary endpoints except PK analysis
Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.
Outcome measures
| Measure |
INS018_055 30 mg QD
n=13 Participants
Group 1: INS018\_055 once daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 30 mg BID
n=12 Participants
Group 2: INS018\_055 twice daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 60 mg QD
n=10 Participants
Group 3: INS018\_055 once daily up to 12 weeks, high dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
Placebo
n=14 Participants
Group 4: Placebo once or twice daily up to 12 weeks
Placebo: Pharmaceutical formulation: Capsules
Mode of Administration: Oral
|
|---|---|---|---|---|
|
Relative Change From Baseline in Forced Vital Capacity (FVC)
|
-0.7923 percentage change in FVC
Standard Deviation 3.90508
|
0.6821 percentage change in FVC
Standard Deviation 6.09585
|
3.2253 percentage change in FVC
Standard Deviation 5.27457
|
-0.7126 percentage change in FVC
Standard Deviation 8.17452
|
SECONDARY outcome
Timeframe: Week 0/Visit 2 up to Week 12Population: Intent-to-treat Population: The ITT population included any randomized participants. The ITT Population was used for summary of demographic and baseline characteristics, and it was used for analysis of secondary endpoints except PK analysis
Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.
Outcome measures
| Measure |
INS018_055 30 mg QD
n=13 Participants
Group 1: INS018\_055 once daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 30 mg BID
n=12 Participants
Group 2: INS018\_055 twice daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 60 mg QD
n=10 Participants
Group 3: INS018\_055 once daily up to 12 weeks, high dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
Placebo
n=14 Participants
Group 4: Placebo once or twice daily up to 12 weeks
Placebo: Pharmaceutical formulation: Capsules
Mode of Administration: Oral
|
|---|---|---|---|---|
|
Absolute Change From Baseline in FVC in L
|
-0.0270 L
Standard Deviation 0.11368
|
0.0197 L
Standard Deviation 0.14177
|
0.0984 L
Standard Deviation 0.14113
|
-0.0203 L
Standard Deviation 0.18300
|
SECONDARY outcome
Timeframe: Week 0/Visit 2 up to Week 12Population: Intent-to-treat Population: The ITT population included any randomized participant. The ITT Population was used for summary of demographic and baseline characteristics, and it was used for analysis of secondary endpoints except PK analysis.
Absolute change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment
Outcome measures
| Measure |
INS018_055 30 mg QD
n=13 Participants
Group 1: INS018\_055 once daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 30 mg BID
n=12 Participants
Group 2: INS018\_055 twice daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 60 mg QD
n=10 Participants
Group 3: INS018\_055 once daily up to 12 weeks, high dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
Placebo
n=14 Participants
Group 4: Placebo once or twice daily up to 12 weeks
Placebo: Pharmaceutical formulation: Capsules
Mode of Administration: Oral
|
|---|---|---|---|---|
|
Absolute Change in FVC % Predicted
|
-0.6729 Percent predicted
Standard Deviation 2.92554
|
0.6455 Percent predicted
Standard Deviation 3.73482
|
3.0461 Percent predicted
Standard Deviation 4.38853
|
-0.5675 Percent predicted
Standard Deviation 5.44712
|
SECONDARY outcome
Timeframe: Week 0/Visit 2 up to Week 12Population: Intent-to-treat Population: The ITT population included any randomized participant. The ITT Population was used for summary of demographic and baseline characteristics, and it was used for analysis of secondary endpoints except PK analysis
Relative change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment
Outcome measures
| Measure |
INS018_055 30 mg QD
n=13 Participants
Group 1: INS018\_055 once daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 30 mg BID
n=12 Participants
Group 2: INS018\_055 twice daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 60 mg QD
n=10 Participants
Group 3: INS018\_055 once daily up to 12 weeks, high dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
Placebo
n=14 Participants
Group 4: Placebo once or twice daily up to 12 weeks
Placebo: Pharmaceutical formulation: Capsules
Mode of Administration: Oral
|
|---|---|---|---|---|
|
Relative Change in FVC % Predicted
|
-0.6724 Percent predicted
Standard Deviation 4.05537
|
0.4434 Percent predicted
Standard Deviation 5.96895
|
3.2194 Percent predicted
Standard Deviation 5.28129
|
-0.8414 Percent predicted
Standard Deviation 8.31651
|
Adverse Events
INS018_055 30 mg QD
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
INS018_055 30 mg BID
Serious events: 4 serious events
Other events: 15 other events
Deaths: 1 deaths
INS018_055 60 mg QD
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
INS018_055 30 mg QD
n=18 participants at risk
Group 1: INS018\_055 once daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 30 mg BID
n=18 participants at risk
Group 2: INS018\_055 twice daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 60 mg QD
n=18 participants at risk
Group 3: INS018\_055 once daily up to 12 weeks, high dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
Placebo
n=17 participants at risk
Group 4: Placebo once or twice daily up to 12 weeks INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
16.7%
3/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Appendicitis
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Cardiac disorders
Ventricular extrasystoles
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
General disorders
Chest discomfort
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
Other adverse events
| Measure |
INS018_055 30 mg QD
n=18 participants at risk
Group 1: INS018\_055 once daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 30 mg BID
n=18 participants at risk
Group 2: INS018\_055 twice daily up to 12 weeks, low dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
INS018_055 60 mg QD
n=18 participants at risk
Group 3: INS018\_055 once daily up to 12 weeks, high dose INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
Placebo
n=17 participants at risk
Group 4: Placebo once or twice daily up to 12 weeks INS018\_055: Pharmaceutical formulation: Capsules Mode of administration: Oral
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
33.3%
6/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
22.2%
4/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.8%
2/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Blood urea increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
C-reactive protein increased
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Carbohydrate antigen 19-9 increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Protein urine present
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Weight decreased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Bile acids increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Blood fibrinogen increased
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Blood glucose increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Blood pressure increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Carotid intima-media thickness increased
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Electrocardiogram ST segment abnormal
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Electrocardiogram high voltage
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Glutamate dehydrogenase increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Immunoglobulins increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Interferon gamma level increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Neutrophil count increased
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
QRS axis abnormal
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Throxine free decreased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Tri-iodothyronine increased
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
Weight increased
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Investigations
White blood cell count increased
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
22.2%
4/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
17.6%
3/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.8%
2/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Infection
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Oral herpes
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Paronychia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
3/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
27.8%
5/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
22.2%
4/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.8%
2/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
22.2%
4/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
16.7%
3/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.8%
2/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
16.7%
3/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
27.8%
5/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Blood and lymphatic system disorders
Eosinophilia myalgia syndrome
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Cardiac disorders
Atrioventricular block first degree
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Cardiac disorders
Aortic valve incompetence
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Cardiac disorders
Bundle branch block left
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Cardiac disorders
Left ventricular dysfunction
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Eye disorders
Eye swelling
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Eye disorders
Vision blurred
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
General disorders
Chest discomfort
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
General disorders
Fatigue
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
General disorders
Influenza like illness
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Renal and urinary disorders
Haematuria
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
11.1%
2/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Renal and urinary disorders
Proteinuria
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.9%
1/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
|
Reproductive system and breast disorders
Prostatic calcification
|
5.6%
1/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/18 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
0.00%
0/17 • Adverse events (AEs) were collected from the signing of the informed consent form (ICF) until end of study (EOS) visit i.e. up to 13 weeks (+10 days).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with a medicinal product, whether or not related. The following are also recorded as an AE: worsening of pre-existing conditions and clinically relevant changes in tests (as per the investigator). Within a system organ class and preferred term, participants may report \>1 AE. Participants are counted once per relationship, preferred term, and system organ class.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place