Trial Outcomes & Findings for COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA (NCT NCT04732468)
NCT ID: NCT04732468
Last Updated: 2024-10-15
Results Overview
Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
1 week post final vaccine administration
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on days 15 (boost) and 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
10
|
10
|
4
|
|
Overall Study
COMPLETED
|
1
|
10
|
10
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA
Baseline characteristics by cohort
| Measure |
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 9.67 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 10.75 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 5.80 • n=4 Participants
|
41.8 years
STANDARD_DEVIATION 9.24 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Healthy volunteers with a negative for SARS-CoV-2 test
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 week post final vaccine administrationPopulation: Analysis population is all subjects who received at least one dose of study intervention (safety analysis population)
Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
Outcome measures
| Measure |
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
|---|---|---|---|---|
|
Incidence of Solicited Local Reactogenicity AEs
|
3 Participants
|
8 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 1 week post final vaccine administrationPopulation: Analysis population is all subjects who received at least one dose of study intervention (safety analysis population)
Incidence of Solicited Systemic Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
Outcome measures
| Measure |
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
|---|---|---|---|---|
|
Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs
|
4 Participants
|
9 Participants
|
7 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 1 week post final vaccine administrationIncidence of Unsolicited AEs Through 1 Week Post Final Vaccine Administration
Outcome measures
| Measure |
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
|---|---|---|---|---|
|
Incidence of Unsolicited AEs
|
2 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 1 week post final vaccine administrationIncidence of Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
Outcome measures
| Measure |
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
|---|---|---|---|---|
|
Incidence of Unsolicited Treatment-Related AEs
|
1 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 30 days post final vaccineIncidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
Outcome measures
| Measure |
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
|---|---|---|---|---|
|
Incidence of Unsolicited AEs
|
2 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 30 Days Post FinalIncidence of Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
Outcome measures
| Measure |
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
|---|---|---|---|---|
|
Incidence of Unsolicited Treatment-Related AEs
|
1 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 6 Months post final vaccine administrationIncidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
Outcome measures
| Measure |
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
|---|---|---|---|---|
|
Incidence of MAAEs
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 Months Post Final VaccineIncidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration
Outcome measures
| Measure |
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=10 Participants
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)
n=4 Participants
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
|
|---|---|---|---|---|
|
Incidence of Serious AEs
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Group 1:Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 1: Cohort 2
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 1:Cohort 3
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 1:Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2: Cohort 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2: Cohort 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2: Cohort 3
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 2: Cohort 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 3:Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 3: Cohort 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3: Cohort 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3: Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 4: Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 4: Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 4: Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 4: Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 5: Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 5:Cohort 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 5: Cohort 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 5: Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 6: Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 6: Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 6: Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 6: Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 7: Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 7: Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 7:Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 7: Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1:Cohort 1
n=4 participants at risk
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 1: Cohort 2
n=10 participants at risk
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 1:Cohort 3
n=10 participants at risk
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 1:Cohort 4
n=4 participants at risk
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 2: Cohort 1
n=4 participants at risk
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 2: Cohort 2
n=10 participants at risk
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 2: Cohort 3
n=10 participants at risk
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 2: Cohort 4
n=4 participants at risk
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 3:Cohort 1
n=4 participants at risk
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 3: Cohort 2
n=10 participants at risk
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 3: Cohort 3
n=10 participants at risk
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 3: Cohort 4
n=4 participants at risk
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 4: Cohort 1
n=4 participants at risk
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 4: Cohort 2
n=10 participants at risk
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 4: Cohort 3
n=10 participants at risk
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 4: Cohort 4
n=4 participants at risk
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 5: Cohort 1
n=4 participants at risk
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 5:Cohort 2
n=10 participants at risk
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 5: Cohort 3
n=10 participants at risk
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 5: Cohort 4
n=4 participants at risk
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 6: Cohort 1
n=4 participants at risk
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 6: Cohort 2
n=10 participants at risk
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 6: Cohort 3
n=10 participants at risk
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 6: Cohort 4
n=4 participants at risk
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 7: Cohort 1
n=4 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 7: Cohort 2
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 7:Cohort 3
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 7: Cohort 4
n=4 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
Other adverse events
| Measure |
Group 1:Cohort 1
n=4 participants at risk
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 1: Cohort 2
n=10 participants at risk
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 1:Cohort 3
n=10 participants at risk
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 1:Cohort 4
n=4 participants at risk
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 2: Cohort 1
n=4 participants at risk
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 2: Cohort 2
n=10 participants at risk
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 2: Cohort 3
n=10 participants at risk
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 2: Cohort 4
n=4 participants at risk
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
|
Group 3:Cohort 1
n=4 participants at risk
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 3: Cohort 2
n=10 participants at risk
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 3: Cohort 3
n=10 participants at risk
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 3: Cohort 4
n=4 participants at risk
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 4: Cohort 1
n=4 participants at risk
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 4: Cohort 2
n=10 participants at risk
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 4: Cohort 3
n=10 participants at risk
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 4: Cohort 4
n=4 participants at risk
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 5: Cohort 1
n=4 participants at risk
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 5:Cohort 2
n=10 participants at risk
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 5: Cohort 3
n=10 participants at risk
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 5: Cohort 4
n=4 participants at risk
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 6: Cohort 1
n=4 participants at risk
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 6: Cohort 2
n=10 participants at risk
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 6: Cohort 3
n=10 participants at risk
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 6: Cohort 4
n=4 participants at risk
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 7: Cohort 1
n=4 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 7: Cohort 2
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 7:Cohort 3
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 7: Cohort 4
n=4 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
75.0%
3/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
60.0%
6/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
75.0%
3/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Injection site erythema
|
75.0%
3/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
30.0%
3/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Injection site pruritus
|
50.0%
2/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
30.0%
3/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
50.0%
2/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Injection site reaction
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
40.0%
4/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Injection site swelling
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
100.0%
4/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
80.0%
8/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
60.0%
6/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
100.0%
4/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Chills
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
50.0%
2/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
40.0%
4/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Nausea
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
50.0%
2/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
70.0%
7/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
40.0%
4/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
40.0%
4/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
60.0%
6/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
30.0%
3/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
50.0%
2/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
30.0%
3/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
50.0%
5/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
40.0%
4/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
50.0%
2/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Feeling abnormal
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Feeling hot
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Injection site induration
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Swelling Face
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
30.0%
3/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
30.0%
3/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
50.0%
2/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
50.0%
2/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
20.0%
2/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Eye disorders
Eye discharge
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
25.0%
1/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Congenital, familial and genetic disorders
Ehlers-Danlos syndrome
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
10.0%
1/10 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
0.00%
0/4 • Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place