Trial Outcomes & Findings for A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults (NCT NCT05960097)
NCT ID: NCT05960097
Last Updated: 2025-10-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
692 participants
Primary outcome timeframe
At Day 29
Results posted on
2025-10-23
Participant Flow
A total of 692 participants were included in enrolled set out of which only 686 were included in exposed set and started the study.
Participant milestones
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
87
|
84
|
84
|
85
|
85
|
86
|
87
|
88
|
|
Overall Study
COMPLETED
|
83
|
83
|
82
|
82
|
83
|
85
|
84
|
85
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
2
|
3
|
2
|
1
|
3
|
3
|
Reasons for withdrawal
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
2
|
1
|
1
|
2
|
3
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Early Withdrawal: Participant relocated and cannot attend the site
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The Age Continuous analysis is presented separately for Part A and B.
Baseline characteristics by cohort
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=87 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=84 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=84 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=85 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=85 Participants
Participants received one dose of the control vaccine at Day 1.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
n=86 Participants
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
n=87 Participants
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
n=88 Participants
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
|
Total
n=686 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Part A
|
54.1 Years
STANDARD_DEVIATION 16.71 • n=87 Participants • The Age Continuous analysis is presented separately for Part A and B.
|
53.3 Years
STANDARD_DEVIATION 16.94 • n=84 Participants • The Age Continuous analysis is presented separately for Part A and B.
|
52.5 Years
STANDARD_DEVIATION 16.61 • n=84 Participants • The Age Continuous analysis is presented separately for Part A and B.
|
53.9 Years
STANDARD_DEVIATION 15.53 • n=85 Participants • The Age Continuous analysis is presented separately for Part A and B.
|
54.2 Years
STANDARD_DEVIATION 16.66 • n=85 Participants • The Age Continuous analysis is presented separately for Part A and B.
|
—
|
—
|
—
|
53.6 Years
STANDARD_DEVIATION 16.53 • n=425 Participants • The Age Continuous analysis is presented separately for Part A and B.
|
|
Age, Continuous
Part B
|
—
|
—
|
—
|
—
|
—
|
53.4 Years
STANDARD_DEVIATION 17.94 • n=86 Participants • The Age Continuous analysis is presented separately for Part A and B.
|
53.2 Years
STANDARD_DEVIATION 17.25 • n=87 Participants • The Age Continuous analysis is presented separately for Part A and B.
|
54.3 Years
STANDARD_DEVIATION 16.76 • n=88 Participants • The Age Continuous analysis is presented separately for Part A and B.
|
53.6 Years
STANDARD_DEVIATION 17.26 • n=261 Participants • The Age Continuous analysis is presented separately for Part A and B.
|
|
Sex: Female, Male
Female
|
45 Participants
n=87 Participants
|
41 Participants
n=84 Participants
|
37 Participants
n=84 Participants
|
45 Participants
n=85 Participants
|
38 Participants
n=85 Participants
|
42 Participants
n=86 Participants
|
39 Participants
n=87 Participants
|
47 Participants
n=88 Participants
|
334 Participants
n=686 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=87 Participants
|
43 Participants
n=84 Participants
|
47 Participants
n=84 Participants
|
40 Participants
n=85 Participants
|
47 Participants
n=85 Participants
|
44 Participants
n=86 Participants
|
48 Participants
n=87 Participants
|
41 Participants
n=88 Participants
|
352 Participants
n=686 Participants
|
|
Race/Ethnicity, Customized
Aboriginal Australian
|
0 Participants
n=87 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=85 Participants
|
2 Participants
n=86 Participants
|
1 Participants
n=87 Participants
|
1 Participants
n=88 Participants
|
4 Participants
n=686 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=87 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=84 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=88 Participants
|
1 Participants
n=686 Participants
|
|
Race/Ethnicity, Customized
Japanese Origin
|
0 Participants
n=87 Participants
|
1 Participants
n=84 Participants
|
2 Participants
n=84 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=86 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=88 Participants
|
4 Participants
n=686 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=87 Participants
|
7 Participants
n=84 Participants
|
8 Participants
n=84 Participants
|
7 Participants
n=85 Participants
|
9 Participants
n=85 Participants
|
8 Participants
n=86 Participants
|
11 Participants
n=87 Participants
|
8 Participants
n=88 Participants
|
64 Participants
n=686 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=87 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=86 Participants
|
1 Participants
n=87 Participants
|
1 Participants
n=88 Participants
|
3 Participants
n=686 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=87 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=84 Participants
|
3 Participants
n=85 Participants
|
1 Participants
n=85 Participants
|
0 Participants
n=86 Participants
|
1 Participants
n=87 Participants
|
0 Participants
n=88 Participants
|
7 Participants
n=686 Participants
|
|
Race/Ethnicity, Customized
White
|
77 Participants
n=87 Participants
|
76 Participants
n=84 Participants
|
73 Participants
n=84 Participants
|
73 Participants
n=85 Participants
|
73 Participants
n=85 Participants
|
73 Participants
n=86 Participants
|
72 Participants
n=87 Participants
|
76 Participants
n=88 Participants
|
593 Participants
n=686 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 Participants
n=87 Participants
|
1 Participants
n=84 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=85 Participants
|
1 Participants
n=85 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=87 Participants
|
1 Participants
n=88 Participants
|
6 Participants
n=686 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=87 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=84 Participants
|
1 Participants
n=85 Participants
|
1 Participants
n=85 Participants
|
1 Participants
n=86 Participants
|
0 Participants
n=87 Participants
|
1 Participants
n=88 Participants
|
5 Participants
n=686 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=87 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=88 Participants
|
1 Participants
n=686 Participants
|
|
Race/Ethnicity, Customized
Other, Unspecified
|
0 Participants
n=87 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=86 Participants
|
1 Participants
n=87 Participants
|
0 Participants
n=88 Participants
|
2 Participants
n=686 Participants
|
PRIMARY outcome
Timeframe: At Day 29Population: Analysis was performed on the Per Protocol Set (PPS) which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=78 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=74 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=75 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=74 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=79 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
|
1266.7 Titers
Interval 1008.1 to 1591.7
|
1786.9 Titers
Interval 1409.1 to 2265.9
|
2122.1 Titers
Interval 1681.9 to 2677.4
|
2218.6 Titers
Interval 1751.4 to 2810.5
|
1725.5 Titers
Interval 1367.6 to 2177.0
|
PRIMARY outcome
Timeframe: At Day 29Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=78 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=74 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=75 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=74 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=80 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
|
3725.0 Titers
Interval 3116.4 to 4452.5
|
4680.6 Titers
Interval 3886.5 to 5637.0
|
5275.7 Titers
Interval 4397.6 to 6329.1
|
5261.2 Titers
Interval 4368.3 to 6336.5
|
4863.4 Titers
Interval 4058.1 to 5828.5
|
PRIMARY outcome
Timeframe: At Day 29Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=77 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=78 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=80 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
|
5658.8 Titers
Interval 4762.8 to 6723.4
|
4889.4 Titers
Interval 4097.4 to 5834.5
|
4629.7 Titers
Interval 3892.7 to 5506.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=87 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=84 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=84 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=85 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=85 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Pain
|
34 Participants
|
46 Participants
|
53 Participants
|
40 Participants
|
54 Participants
|
|
Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Swelling
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Redness
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Lymphadenopathy
|
7 Participants
|
10 Participants
|
15 Participants
|
12 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature is higher than or equal to (\>=) 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=87 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=84 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=84 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=85 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=85 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: Number of Participants Reporting Any Solicited Systemic AEs
Fatigue
|
30 Participants
|
26 Participants
|
40 Participants
|
24 Participants
|
34 Participants
|
|
Part A: Number of Participants Reporting Any Solicited Systemic AEs
Headache
|
20 Participants
|
30 Participants
|
37 Participants
|
27 Participants
|
28 Participants
|
|
Part A: Number of Participants Reporting Any Solicited Systemic AEs
Arthralgia
|
9 Participants
|
7 Participants
|
13 Participants
|
4 Participants
|
14 Participants
|
|
Part A: Number of Participants Reporting Any Solicited Systemic AEs
Fever
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Part A: Number of Participants Reporting Any Solicited Systemic AEs
Myalgia
|
14 Participants
|
20 Participants
|
35 Participants
|
25 Participants
|
28 Participants
|
|
Part A: Number of Participants Reporting Any Solicited Systemic AEs
Chills
|
5 Participants
|
9 Participants
|
11 Participants
|
3 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 28Population: Analysis was performed on the Exposed Set (ES) which includes all participants who received the study intervention and had unsolicited AEs data available post-vaccination for the specified duration.
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=87 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=84 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=84 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=85 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=85 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: Number of Participants Reporting Any Unsolicited AEs
|
20 Participants
|
22 Participants
|
21 Participants
|
27 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 181Population: Analysis was performed on the ES which includes all participants who received the study intervention and had post-vaccination data available for the specified duration.
An SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or extends existing hospitalization, causes persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participant's offspring, includes an abnormal pregnancy outcome, or occurs in any other situation per the investigator's judgement. An MAAE results in a visit to a medical professional, such as televisits, physician's office visits, urgent care visits, emergency rooms visits, or hospitalizations. AESIs are severe or non-severe predefined AEs of scientific and medical concern specific to the product/program. This study noted the following AESIs: potential immune-mediated disease (pIMDs), lab-confirmed moderate to severe COVID-19, myocarditis and pericarditis, anaphylaxis, or severe hypersensitivity within 24 hours post-intervention. "Any" indicates the occurrence of the event regardless of its intensity grade.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=87 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=84 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=84 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=85 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=85 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
MAAEs
|
29 Participants
|
21 Participants
|
25 Participants
|
31 Participants
|
30 Participants
|
|
Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
SAEs
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
AESIs
|
7 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=86 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=87 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=88 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part B: Number of Participants Reporting Any Solicited Administration Site AEs
Pain
|
34 Participants
|
42 Participants
|
42 Participants
|
—
|
—
|
|
Part B: Number of Participants Reporting Any Solicited Administration Site AEs
Swelling
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants Reporting Any Solicited Administration Site AEs
Redness
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants Reporting Any Solicited Administration Site AEs
Lymphadenopathy
|
6 Participants
|
5 Participants
|
10 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature \>= 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=86 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=87 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=88 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part B: Number of Participants Reporting Any Solicited Systemic AEs
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants Reporting Any Solicited Systemic AEs
Myalgia
|
11 Participants
|
21 Participants
|
19 Participants
|
—
|
—
|
|
Part B: Number of Participants Reporting Any Solicited Systemic AEs
Chills
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants Reporting Any Solicited Systemic AEs
Fatigue
|
28 Participants
|
28 Participants
|
28 Participants
|
—
|
—
|
|
Part B: Number of Participants Reporting Any Solicited Systemic AEs
Headache
|
19 Participants
|
15 Participants
|
28 Participants
|
—
|
—
|
|
Part B: Number of Participants Reporting Any Solicited Systemic AEs
Arthralgia
|
6 Participants
|
9 Participants
|
9 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 28Population: Analysis was performed on the ES which includes all participants who received the study intervention and had unsolicited AEs data available post-vaccination for the specified duration.
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=86 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=87 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=88 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part B: Number of Participants Reporting Any Unsolicited AEs
|
17 Participants
|
18 Participants
|
18 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 181Population: Analysis was performed on the ES which includes all participants who received the study intervention and had post-vaccination data available for the specified duration.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=86 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=87 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=88 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs
MAAEs
|
24 Participants
|
26 Participants
|
23 Participants
|
—
|
—
|
|
Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs
SAEs
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs
AESIs
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 91 and Day 181Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=71 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=66 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=73 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=71 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=67 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Day 91
|
872.5 Titers
Interval 686.0 to 1109.7
|
1181.9 Titers
Interval 914.8 to 1527.0
|
1477.7 Titers
Interval 1160.4 to 1881.8
|
1527.8 Titers
Interval 1196.7 to 1950.4
|
1155.6 Titers
Interval 896.6 to 1489.3
|
|
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Day 181
|
585.0 Titers
Interval 444.3 to 770.3
|
797.0 Titers
Interval 600.2 to 1058.5
|
977.6 Titers
Interval 738.2 to 1294.6
|
1032.6 Titers
Interval 777.1 to 1372.2
|
734.2 Titers
Interval 546.9 to 985.7
|
SECONDARY outcome
Timeframe: At Day 91 and Day 181Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=71 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=66 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=73 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=71 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=68 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Day 91
|
2637.0 Titers
Interval 2198.6 to 3162.9
|
3714.0 Titers
Interval 3058.0 to 4510.8
|
4284.9 Titers
Interval 3566.3 to 5148.4
|
3952.1 Titers
Interval 3281.3 to 4760.0
|
3216.5 Titers
Interval 2656.1 to 3895.1
|
|
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Day 181
|
2215.8 Titers
Interval 1779.5 to 2759.0
|
2935.4 Titers
Interval 2342.8 to 3677.9
|
3319.3 Titers
Interval 2653.8 to 4151.6
|
3243.6 Titers
Interval 2584.7 to 4070.5
|
2640.6 Titers
Interval 2095.6 to 3327.2
|
SECONDARY outcome
Timeframe: At Day 29, Day 91 and Day 181Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XZ spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=78 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=73 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=74 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=74 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=80 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Day 29
|
196.0 Titers
Interval 155.1 to 247.7
|
281.5 Titers
Interval 220.6 to 359.3
|
335.0 Titers
Interval 262.4 to 427.6
|
404.3 Titers
Interval 316.8 to 515.9
|
265.7 Titers
Interval 209.2 to 337.5
|
|
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Day 91
|
139.8 Titers
Interval 108.1 to 180.9
|
188.6 Titers
Interval 142.8 to 249.1
|
259.6 Titers
Interval 199.3 to 338.2
|
259.5 Titers
Interval 199.6 to 337.2
|
194.5 Titers
Interval 148.2 to 255.3
|
|
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Day 181
|
105.3 Titers
Interval 78.7 to 140.9
|
131.1 Titers
Interval 97.3 to 176.7
|
170.2 Titers
Interval 125.7 to 230.5
|
180.2 Titers
Interval 133.5 to 243.1
|
117.2 Titers
Interval 85.9 to 159.7
|
SECONDARY outcome
Timeframe: At Day 29 compared to baseline (Day 1)Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Seroresponse is defined as post-booster titer greater than or equal to (≥) 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=78 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=74 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=75 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=74 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=79 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
|
38.5 Percentage of participants
Interval 27.66 to 50.17
|
50.0 Percentage of participants
Interval 38.14 to 61.86
|
50.7 Percentage of participants
Interval 38.86 to 62.42
|
51.4 Percentage of participants
Interval 39.44 to 63.15
|
48.1 Percentage of participants
Interval 36.71 to 59.64
|
SECONDARY outcome
Timeframe: At Day 29 compared to baseline (Day 1)Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Seroresponse is defined as post-booster titer ≥ 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=78 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=74 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=75 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=74 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=80 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
|
17.9 Percentage of participants
Interval 10.17 to 28.28
|
25.7 Percentage of participants
Interval 16.22 to 37.16
|
29.3 Percentage of participants
Interval 19.38 to 40.98
|
25.7 Percentage of participants
Interval 16.22 to 37.16
|
35.0 Percentage of participants
Interval 24.67 to 46.48
|
SECONDARY outcome
Timeframe: At Day 29 compared to baseline (Day 1)Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XZ spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Seroresponse is defined as post-booster titer ≥ 4 times the LLOQ when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=78 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=73 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=74 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=74 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=80 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
|
39.7 Percentage of participants
Interval 28.83 to 51.46
|
43.8 Percentage of participants
Interval 32.24 to 55.95
|
55.4 Percentage of participants
Interval 43.39 to 66.98
|
47.3 Percentage of participants
Interval 35.57 to 59.25
|
47.5 Percentage of participants
Interval 36.21 to 58.98
|
SECONDARY outcome
Timeframe: At Day 29, Day 91 and Day 181 compared to baseline (Day 1)Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=78 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=74 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=75 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=74 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=79 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Day 29
|
2.72 Ratio
Interval 2.17 to 3.42
|
3.84 Ratio
Interval 3.03 to 4.87
|
4.56 Ratio
Interval 3.62 to 5.75
|
4.77 Ratio
Interval 3.76 to 6.04
|
3.71 Ratio
Interval 2.94 to 4.68
|
|
Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Day 91
|
1.69 Ratio
Interval 1.33 to 2.15
|
2.29 Ratio
Interval 1.77 to 2.95
|
2.86 Ratio
Interval 2.24 to 3.64
|
2.95 Ratio
Interval 2.31 to 3.77
|
2.23 Ratio
Interval 1.73 to 2.88
|
|
Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Day 181
|
0.96 Ratio
Interval 0.73 to 1.27
|
1.31 Ratio
Interval 0.99 to 1.74
|
1.61 Ratio
Interval 1.21 to 2.13
|
1.70 Ratio
Interval 1.28 to 2.26
|
1.21 Ratio
Interval 0.9 to 1.62
|
SECONDARY outcome
Timeframe: At Day 29, Day 91 and Day 181 compared to baseline (Day 1)Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=78 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=74 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=75 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=74 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=80 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Day 29
|
2.14 Ratio
Interval 1.79 to 2.55
|
2.68 Ratio
Interval 2.23 to 3.23
|
3.03 Ratio
Interval 2.52 to 3.63
|
3.02 Ratio
Interval 2.51 to 3.63
|
2.79 Ratio
Interval 2.33 to 3.34
|
|
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Day 91
|
1.41 Ratio
Interval 1.17 to 1.69
|
1.98 Ratio
Interval 1.63 to 2.41
|
2.28 Ratio
Interval 1.9 to 2.75
|
2.11 Ratio
Interval 1.75 to 2.54
|
1.72 Ratio
Interval 1.42 to 2.08
|
|
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Day 181
|
1.07 Ratio
Interval 0.86 to 1.34
|
1.42 Ratio
Interval 1.14 to 1.78
|
1.61 Ratio
Interval 1.29 to 2.01
|
1.57 Ratio
Interval 1.25 to 1.97
|
1.28 Ratio
Interval 1.02 to 1.61
|
SECONDARY outcome
Timeframe: At Day 29, Day 91 and Day 181 compared to baseline (Day 1)Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XZ spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Outcome measures
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=78 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=73 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=74 Participants
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=74 Participants
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=80 Participants
Participants received one dose of the control vaccine at Day 1.
|
|---|---|---|---|---|---|
|
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Day 29
|
2.66 Ratio
Interval 2.11 to 3.36
|
3.82 Ratio
Interval 3.0 to 4.88
|
4.55 Ratio
Interval 3.56 to 5.81
|
5.49 Ratio
Interval 4.3 to 7.0
|
3.61 Ratio
Interval 2.84 to 4.58
|
|
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Day 91
|
1.78 Ratio
Interval 1.37 to 2.3
|
2.40 Ratio
Interval 1.82 to 3.17
|
3.30 Ratio
Interval 2.53 to 4.3
|
3.30 Ratio
Interval 2.54 to 4.29
|
2.47 Ratio
Interval 1.88 to 3.25
|
|
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Day 181
|
1.16 Ratio
Interval 0.86 to 1.55
|
1.44 Ratio
Interval 1.07 to 1.94
|
1.87 Ratio
Interval 1.38 to 2.53
|
1.98 Ratio
Interval 1.47 to 2.67
|
1.29 Ratio
Interval 0.94 to 1.76
|
Adverse Events
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Serious events: 3 serious events
Other events: 64 other events
Deaths: 0 deaths
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Serious events: 0 serious events
Other events: 68 other events
Deaths: 0 deaths
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Serious events: 3 serious events
Other events: 72 other events
Deaths: 0 deaths
Part A: CV0601 mRNA COVID-19 Vaccine
Serious events: 1 serious events
Other events: 62 other events
Deaths: 0 deaths
Part A: Control Vaccine
Serious events: 3 serious events
Other events: 75 other events
Deaths: 0 deaths
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
Serious events: 2 serious events
Other events: 62 other events
Deaths: 0 deaths
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
Serious events: 4 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=87 participants at risk
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=84 participants at risk
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=84 participants at risk
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=85 participants at risk
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=85 participants at risk
Participants received one dose of the control vaccine at Day 1.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
n=86 participants at risk
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
n=87 participants at risk
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
n=88 participants at risk
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Abscess limb
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Endocarditis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Ophthalmic herpes simplex
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Nervous system disorders
Syncope
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Renal and urinary disorders
Ureterolithiasis
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Reproductive system and breast disorders
Endometrial hyperplasia with cellular atypia
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
Other adverse events
| Measure |
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
n=87 participants at risk
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
n=84 participants at risk
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
|
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
n=84 participants at risk
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
|
Part A: CV0601 mRNA COVID-19 Vaccine
n=85 participants at risk
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
|
Part A: Control Vaccine
n=85 participants at risk
Participants received one dose of the control vaccine at Day 1.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
n=86 participants at risk
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
n=87 participants at risk
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
|
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
n=88 participants at risk
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
8.0%
7/87 • Number of events 7 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
11.9%
10/84 • Number of events 10 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
17.9%
15/84 • Number of events 15 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
14.1%
12/85 • Number of events 12 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
11.8%
10/85 • Number of events 10 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
7.0%
6/86 • Number of events 6 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
5.7%
5/87 • Number of events 5 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
11.4%
10/88 • Number of events 10 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Cardiac disorders
Palpitations
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.3%
2/87 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/85 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
3.4%
3/88 • Number of events 3 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Chest discomfort
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Chills
|
5.7%
5/87 • Number of events 5 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
10.7%
9/84 • Number of events 9 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
13.1%
11/84 • Number of events 11 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
3.5%
3/85 • Number of events 3 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
10.6%
9/85 • Number of events 9 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.3%
2/87 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Fatigue
|
34.5%
30/87 • Number of events 30 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
32.1%
27/84 • Number of events 27 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
47.6%
40/84 • Number of events 40 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
29.4%
25/85 • Number of events 25 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
40.0%
34/85 • Number of events 34 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
32.6%
28/86 • Number of events 28 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
32.2%
28/87 • Number of events 29 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
31.8%
28/88 • Number of events 28 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Fever
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/84 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/85 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
3.5%
3/85 • Number of events 3 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Injection site erythema
|
2.3%
2/87 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
3.6%
3/84 • Number of events 3 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/84 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/85 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
3.4%
3/88 • Number of events 3 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Injection site pain
|
39.1%
34/87 • Number of events 34 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
54.8%
46/84 • Number of events 46 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
63.1%
53/84 • Number of events 53 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
47.1%
40/85 • Number of events 40 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
63.5%
54/85 • Number of events 54 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
39.5%
34/86 • Number of events 34 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
48.3%
42/87 • Number of events 42 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
47.7%
42/88 • Number of events 42 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Injection site pruritus
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Injection site swelling
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
3.6%
3/84 • Number of events 3 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
3.5%
3/86 • Number of events 3 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.3%
2/87 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Polyp
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Vessel puncture site bruise
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/85 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Bronchitis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
COVID-19
|
11.5%
10/87 • Number of events 10 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
6.0%
5/84 • Number of events 5 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
9.5%
8/84 • Number of events 8 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
5.9%
5/85 • Number of events 5 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
14.1%
12/85 • Number of events 12 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
4.7%
4/86 • Number of events 4 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
4.6%
4/87 • Number of events 4 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
5.7%
5/88 • Number of events 5 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Carbuncle
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Cystitis
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Folliculitis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.3%
2/87 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Gingivitis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Oral herpes
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Rhinitis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/84 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Rhinovirus infection
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Sinusitis
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Staphylococcal skin infection
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Suspected COVID-19
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Syphilis
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Tooth infection
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
2/87 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
6.0%
5/84 • Number of events 6 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/85 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/85 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
3.4%
3/88 • Number of events 3 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.3%
2/86 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/85 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Infections and infestations
Wound infection
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Injury, poisoning and procedural complications
Tooth injury
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Investigations
Vitamin D decreased
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/84 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
9/87 • Number of events 9 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
8.3%
7/84 • Number of events 7 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
16.7%
14/84 • Number of events 14 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
4.7%
4/85 • Number of events 4 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
16.5%
14/85 • Number of events 14 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
7.0%
6/86 • Number of events 6 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
10.3%
9/87 • Number of events 9 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
10.2%
9/88 • Number of events 9 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/85 • Number of events 3 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.1%
14/87 • Number of events 14 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
25.0%
21/84 • Number of events 21 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
41.7%
35/84 • Number of events 35 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
29.4%
25/85 • Number of events 25 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
32.9%
28/85 • Number of events 28 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
12.8%
11/86 • Number of events 11 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
24.1%
21/87 • Number of events 21 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
21.6%
19/88 • Number of events 19 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Nervous system disorders
Dizziness
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.3%
2/87 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Nervous system disorders
Headache
|
23.0%
20/87 • Number of events 20 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
35.7%
30/84 • Number of events 30 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
44.0%
37/84 • Number of events 37 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
31.8%
27/85 • Number of events 27 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
34.1%
29/85 • Number of events 29 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
22.1%
19/86 • Number of events 19 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
17.2%
15/87 • Number of events 15 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
31.8%
28/88 • Number of events 29 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Nervous system disorders
Lethargy
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Nervous system disorders
Migraine
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Nervous system disorders
Transient aphasia
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Psychiatric disorders
Depression
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.3%
2/87 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Psychiatric disorders
Irritability
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Psychiatric disorders
Nightmare
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Psychiatric disorders
Sleep disorder
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/85 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
3.5%
3/85 • Number of events 3 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.3%
2/87 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.3%
2/87 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/86 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/85 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/87 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.2%
1/84 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/88 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
|
Vascular disorders
Hypertension
|
1.1%
1/87 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/84 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
2.4%
2/85 • Number of events 2 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/85 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/86 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
0.00%
0/87 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
1.1%
1/88 • Number of events 1 • Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER