Trial Outcomes & Findings for Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies (NCT NCT04865419)
NCT ID: NCT04865419
Last Updated: 2025-06-15
Results Overview
The safety and tolerability of AZD0466 in participants with advanced haematological malignancies were assessed.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years)
Results posted on
2025-06-15
Participant Flow
The study was conducted in 2 modules. Module 1 of the study was conducted at 14 sites in 6 countries (Australia, France, Germany, Italy, South Korea, and United States of America \[USA\]). Module 2 of the study was conducted at 6 sites in 2 countries (Australia and USA).
Participants who met all the inclusion and none of the exclusion criteria were enrolled in this study. All study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
Participants received intravenous (IV) infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 300 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 600 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 1200 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
7
|
5
|
10
|
2
|
1
|
3
|
4
|
4
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
7
|
5
|
10
|
2
|
1
|
3
|
4
|
4
|
2
|
Reasons for withdrawal
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
Participants received intravenous (IV) infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 300 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 600 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 1200 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
1
|
2
|
2
|
1
|
3
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
0
|
|
Overall Study
Study terminated by Sponsor
|
0
|
0
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
3
|
1
|
4
|
2
|
5
|
2
|
1
|
1
|
2
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
Baseline characteristics by cohort
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
n=7 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
n=5 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
n=10 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
n=2 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 300 mg+ Voriconazole
n=1 Participants
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 600 mg+ Voriconazole
n=3 Participants
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 1200 mg+ Voriconazole
n=4 Participants
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
n=4 Participants
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
n=2 Participants
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Module 1
|
61.3 Years
STANDARD_DEVIATION 20.07 • n=4 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
72.3 Years
STANDARD_DEVIATION 4.03 • n=4 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
64.6 Years
STANDARD_DEVIATION 14.98 • n=7 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
63.4 Years
STANDARD_DEVIATION 16.91 • n=5 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
62.8 Years
STANDARD_DEVIATION 10.77 • n=10 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
61.5 Years
STANDARD_DEVIATION 10.61 • n=2 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
—
|
—
|
—
|
—
|
—
|
64.2 Years
STANDARD_DEVIATION 12.99 • n=32 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
|
Age, Continuous
Module 2
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Years
STANDARD_DEVIATION NA • n=1 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
74.0 Years
STANDARD_DEVIATION 5.20 • n=3 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
40.0 Years
STANDARD_DEVIATION 20.99 • n=4 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
62.5 Years
STANDARD_DEVIATION 17.08 • n=4 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
71.0 Years
STANDARD_DEVIATION 7.07 • n=2 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
61.0 Years
STANDARD_DEVIATION 19.89 • n=14 Participants • Two separate rows have been created for each module to present the total Mean and S.D. separately for each module as different population of participants were involved in each module.
|
|
Sex/Gender, Customized
Female
|
NA Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
NA Participants
n=2 Participants
|
NA Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=2 Participants
|
NA Participants
n=46 Participants
|
|
Sex/Gender, Customized
Male
|
NA Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
NA Participants
n=2 Participants
|
NA Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=2 Participants
|
NA Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
35 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
9 Participants
n=46 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=46 Participants
|
PRIMARY outcome
Timeframe: From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years)Population: Safety analysis set consisted of all enrolled participants who received at least 1 dose of AZD0466.
The safety and tolerability of AZD0466 in participants with advanced haematological malignancies were assessed.
Outcome measures
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
n=7 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
n=5 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
n=10 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
n=2 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 300 mg- Acute Lymphoblastic Leukaemia (ALL)
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg - ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg- ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any AE
|
4 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any SAE
|
4 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any SAE with outcome death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any AE leading to discontinuation of AZD0466
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any possibly related AE
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any possibly related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any AE leading to AZD0466 dose reduction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any AE leading to AZD0466 dose interruption
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any AE of >= CTCAE grade 3
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
9 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any SAE and/or >= CTCAE grade 3 AE
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
9 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any AE classified as a DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Any possibly related deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years)Population: Safety analysis set consisted of all enrolled participants who received at least 1 dose of AZD0466.
The safety and tolerability of AZD0466 in participants with advanced haematological malignancies were assessed.
Outcome measures
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
n=1 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
n=3 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
n=2 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 300 mg- Acute Lymphoblastic Leukaemia (ALL)
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg - ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg- ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any AE
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any SAE
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any SAE with outcome death
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any AE leading to discontinuation of AZD0466
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any possibly related AE
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any possibly related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any AE leading to AZD0466 dose reduction
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any AE leading to AZD0466 dose interruption
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any AE of >= CTCAE grade 3
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any SAE and/or >= CTCAE grade 3 AE
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any AE classified as a DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Any possibly related deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: upto 35 daysPopulation: DLT-evaluable set consisted of participants enrolled in the dose-escalation that have received at least 3 doses of AZD0466 at the target dose level (75% of target doses from Day 8 to Day 29 in Cycle 1) and have completed the safety follow-up through the DLT evaluation period or have experienced a DLT.
The safety and tolerability of AZD0466 in participants with advanced haematological malignancies were assessed.
Outcome measures
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
n=3 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
n=6 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
n=3 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
n=7 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
n=1 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 300 mg- Acute Lymphoblastic Leukaemia (ALL)
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg - ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg- ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicity (DLT) [Module 1]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 until post treatment follow-up (28 days after last dose) (approximately 2.1 years)Population: Intention to treat (ITT) set consisted of all enrolled participants who received at least 1 dose of AZD0466.
Complete response rate (CR+CRi) is defined as the percentage of participants who have a complete remission (CR) or incomplete haematological response (CRi).
Outcome measures
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
n=2 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
n=6 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
n=5 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
n=8 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
n=2 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 300 mg- Acute Lymphoblastic Leukaemia (ALL)
n=2 Participants
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg - ALL
n=1 Participants
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg- ALL
n=2 Participants
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Module 1: Complete Response Rate
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 until post treatment follow-up (28 days after last dose) (Approximately 2.1 years)Population: ITT set consisted of all enrolled participants who received at least 1 dose of AZD0466. Since none of the participants had achieved CR or CRi, TTR could not be calculated.
Time to response is defined as the time from date of first dose until the date of first documented CR or CRi.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 until post treatment follow-up (28 days after last dose) (approximately 2.1 years)Population: ITT set consisted of all enrolled participants who received at least 1 dose of AZD0466. Since none of the participants had achieved CR or CRi, DoR could not be calculated.
Duration of Response (DoR) will be defined as the time from the date of first documented response (CR+CRi) until date of documented progression, relapse or failure or death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 until post treatment follow-up (28 days after last dose) and survival follow-up (every month after last dose) (approximately 2.1 years)Population: ITT set consisted of all enrolled participants who received at least 1 dose of AZD0466.
Overall survival (OS) is defined as time from date of first dose until the date of death due to any cause.
Outcome measures
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
n=7 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
n=5 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
n=10 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
n=2 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 300 mg- Acute Lymphoblastic Leukaemia (ALL)
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg - ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg- ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Module 1: Overall Survival
|
3.2 Months
Interval 2.7 to
The value was not calculated due to low number of events
|
NA Months
Interval 1.3 to
The value was not calculated due to low number of events
|
3.8 Months
Interval 2.1 to
The value was not calculated due to low number of events
|
NA Months
Interval 1.1 to
The value was not calculated due to low number of events
|
2.4 Months
Interval 0.5 to
The value was not calculated due to low number of events
|
2.0 Months
Interval 0.9 to
The value was not calculated due to low number of events
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1, 2, 3, 4, 8 and days 15, 16, 17, 18, 19, and Cycle 2 Day 1, Cycle 3 Day 1 and beyond (Cycle length 28-days) (approximately 2.1 years)Population: It was pre-specified by the Study Protocol to only analyze dosed participants with at least 1 reportable plasma concentration and no important AEs or protocol deviations that may impact PK for this Outcome Measure. Due to changes in target dose levels and protocol deviations affecting derivation of PK parameters, AUC could not be statistically assessed (summary statistics or inferential statistical comparisons), as no participant met pre-specified criteria for analysis.
Assessment of AUC to evaluate the drug-drug interaction potential between AZD0466 and the azole antifungal voriconazole. For this outcome measure, pharmacokinetics (PK) analysis set was included which consisted of all dosed participants with reportable plasma concentrations and no important AEs or protocol deviations that may affect PK.
Outcome measures
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
n=1 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
n=3 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
n=2 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 300 mg- Acute Lymphoblastic Leukaemia (ALL)
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg - ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg- ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Module 2: Area Under the Plasma Concentration-curve (AUC) of AZD4320 After Administration of AZD0466 Alone and in Combination With Voriconazole
|
NA hours*nanomole/liter (h*nmol/L)
Geometric Coefficient of Variation NA
AUC could not be summarized because no participants met pre-specified analysis criteria due to changes in target dose levels and protocol deviations affecting PK parameter derivation as specified in the study protocol.
|
NA hours*nanomole/liter (h*nmol/L)
Geometric Coefficient of Variation NA
AUC could not be summarized because no participants met pre-specified analysis criteria due to changes in target dose levels and protocol deviations affecting PK parameter derivation as specified in the study protocol.
|
NA hours*nanomole/liter (h*nmol/L)
Geometric Coefficient of Variation NA
AUC could not be summarized because no participants met pre-specified analysis criteria due to changes in target dose levels and protocol deviations affecting PK parameter derivation as specified in the study protocol.
|
NA hours*nanomole/liter (h*nmol/L)
Geometric Coefficient of Variation NA
AUC could not be summarized because no participants met pre-specified analysis criteria due to changes in target dose levels and protocol deviations affecting PK parameter derivation as specified in the study protocol.
|
NA hours*nanomole/liter (h*nmol/L)
Geometric Coefficient of Variation NA
AUC could not be summarized because no participants met pre-specified analysis criteria due to changes in target dose levels and protocol deviations affecting PK parameter derivation as specified in the study protocol.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Days 1, 2, 3, 4, 8 and days 15, 16, 17, 18, 19, and Cycle 2 Day 1, Cycle 3 Day 1 and beyond (Cycle length 28-days) (approximately 2.1 years)Population: It was pre-specified by the Study Protocol to only analyze dosed participants with at least 1 reportable plasma concentration and no important AEs or protocol deviations that may impact PK for this Outcome Measure. Due to changes in target dose levels and protocol deviations affecting derivation of PK parameters, Cmax could not be statistically assessed (summary statistics or inferential statistical comparisons), as no participant met pre-specified criteria for analysis.
Assessment of Cmax to evaluate the drug-drug interaction potential between AZD0466 and the azole antifungal voriconazole. For this outcome measure, PK analysis set was included which consisted of all dosed participants with reportable plasma concentrations and no important AEs or protocol deviations that may affect PK.
Outcome measures
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
n=1 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
n=3 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
n=2 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 300 mg- Acute Lymphoblastic Leukaemia (ALL)
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg - ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg- ALL
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Module 2: Maximum Observed Plasma (Peak) Drug Concentration (Cmax) of AZD4320 After Administration of AZD0466 Alone and in Combination With Voriconazole
|
NA nanomole (nmol)/liter (L)
Geometric Coefficient of Variation NA
Cmax could not be summarized because no participants met pre-specified analysis criteria due to changes in target dose levels and protocol deviations affecting PK parameter derivation as specified in the study protocol.
|
NA nanomole (nmol)/liter (L)
Geometric Coefficient of Variation NA
Cmax could not be summarized because no participants met pre-specified analysis criteria due to changes in target dose levels and protocol deviations affecting PK parameter derivation as specified in the study protocol.
|
NA nanomole (nmol)/liter (L)
Geometric Coefficient of Variation NA
Cmax could not be summarized because no participants met pre-specified analysis criteria due to changes in target dose levels and protocol deviations affecting PK parameter derivation as specified in the study protocol.
|
NA nanomole (nmol)/liter (L)
Geometric Coefficient of Variation NA
Cmax could not be summarized because no participants met pre-specified analysis criteria due to changes in target dose levels and protocol deviations affecting PK parameter derivation as specified in the study protocol.
|
NA nanomole (nmol)/liter (L)
Geometric Coefficient of Variation NA
Cmax could not be summarized because no participants met pre-specified analysis criteria due to changes in target dose levels and protocol deviations affecting PK parameter derivation as specified in the study protocol.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Module 1: Cycle 1 Days 1-30 (Cycle length 21 days) to Cycle 3 Days 1-28, & beyond (Cycle length 28 days); Module 2: Cycle 1 Days 1-8, Days 15-19 (Cycle length 21 days), Cycle 2 Day 1, Cycle 3 Day 1 & beyond (Cycle length 28-days) (approximately 2.1 Years)Population: PK set consisted of all dosed participants with reportable plasma concentrations and no important AEs or protocol deviations that may affect PK. For PK concentration and parameter data, if there were \<3 values available at a time point or if the value was below the lower limit of quantification (BLQ), descriptive statistics were reported as 'Not calculable (NC)' or 'Not Available (NA)'.
Assessment of AZD4320 to characterise the PK profile of AZD0466 following intravenous administration (via PK profiles of the active moiety AZD4320 in plasma).
Outcome measures
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
n=4 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
n=7 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
n=5 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
n=10 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
n=2 Participants
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 300 mg- Acute Lymphoblastic Leukaemia (ALL)
n=1 Participants
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg - ALL
n=3 Participants
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg- ALL
n=4 Participants
Participants received intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
n=4 Participants
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
n=2 Participants
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Module 1 and Module 2: Plasma Concentration of AZD4320
Released AZD4320: Cycle 1/ Day 8
|
528.6 nanomolar (nM)
Geometric Coefficient of Variation 178.7
|
1053 nanomolar (nM)
Geometric Coefficient of Variation 61.18
|
1651 nanomolar (nM)
Geometric Coefficient of Variation 179.8
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
4117 nanomolar (nM)
Geometric Coefficient of Variation 141.6
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
326.9 nanomolar (nM)
Geometric Coefficient of Variation 33.08
|
1440 nanomolar (nM)
Geometric Coefficient of Variation 11.20
|
1745 nanomolar (nM)
Geometric Coefficient of Variation 62.40
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
|
Module 1 and Module 2: Plasma Concentration of AZD4320
Released AZD4320: Cycle 2/ Day 1
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
—
|
1371 nanomolar (nM)
Geometric Coefficient of Variation 98.40
|
1872 nanomolar (nM)
Geometric Coefficient of Variation 196.0
|
4661 nanomolar (nM)
Geometric Coefficient of Variation 83.61
|
—
|
—
|
—
|
—
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
—
|
|
Module 1 and Module 2: Plasma Concentration of AZD4320
Total AZD4320: Cycle 1 /Day 8
|
16220 nanomolar (nM)
Geometric Coefficient of Variation 53.05
|
48910 nanomolar (nM)
Geometric Coefficient of Variation 28.88
|
104700 nanomolar (nM)
Geometric Coefficient of Variation 76.62
|
200400 nanomolar (nM)
Geometric Coefficient of Variation 27.12
|
272800 nanomolar (nM)
Geometric Coefficient of Variation 22.27
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
36150 nanomolar (nM)
Geometric Coefficient of Variation 14.97
|
84700 nanomolar (nM)
Geometric Coefficient of Variation 34.72
|
186100 nanomolar (nM)
Geometric Coefficient of Variation 44.69
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
|
Module 1 and Module 2: Plasma Concentration of AZD4320
Total AZD4320: Cycle 2/ Day 1
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
—
|
82070 nanomolar (nM)
Geometric Coefficient of Variation 17.95
|
221400 nanomolar (nM)
Geometric Coefficient of Variation 33.80
|
314500 nanomolar (nM)
Geometric Coefficient of Variation 25.27
|
—
|
—
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
—
|
NA nanomolar (nM)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants for analysis at that timepoint in accordance with the SAP.
|
—
|
Adverse Events
Module 1: AZD0466 Monotherapy- 300 mg
Serious events: 4 serious events
Other events: 4 other events
Deaths: 3 deaths
Module 1: AZD0466 Monotherapy- 600 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Module 1: AZD0466 Monotherapy- 1200 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Module 1: AZD0466 Monotherapy- 2400 mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Module 1: AZD0466 Monotherapy- 3600 mg
Serious events: 8 serious events
Other events: 9 other events
Deaths: 5 deaths
Module 1: AZD0466 Monotherapy- 5400 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Module 2: AZD0466 300 mg+ Voriconazole
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Module 2: AZD0466 600 mg+ Voriconazole
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Module 2: AZD0466 1200 mg+ Voriconazole
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Module 2: AZD0466 2400 mg+ Voriconazole
Serious events: 4 serious events
Other events: 4 other events
Deaths: 2 deaths
Module 2: AZD0466 3600 mg+ Voriconazole
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
n=4 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
n=4 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
n=7 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
n=5 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
n=10 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
n=2 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 300 mg+ Voriconazole
n=1 participants at risk
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 600 mg+ Voriconazole
n=3 participants at risk
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 1200 mg+ Voriconazole
n=4 participants at risk
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
n=4 participants at risk
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
n=2 participants at risk
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Acute sinusitis
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Liver abscess
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Mastoiditis
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Pneumonia
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
40.0%
2/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Pneumonia fungal
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Troponin T increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Troponin increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
Other adverse events
| Measure |
Module 1: AZD0466 Monotherapy- 300 mg
n=4 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 600 mg
n=4 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 1200 mg
n=7 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 2400 mg
n=5 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 3600 mg
n=10 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 1: AZD0466 Monotherapy- 5400 mg
n=2 participants at risk
Participants received IV infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 300 mg+ Voriconazole
n=1 participants at risk
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 600 mg+ Voriconazole
n=3 participants at risk
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 1200 mg+ Voriconazole
n=4 participants at risk
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 2400 mg+ Voriconazole
n=4 participants at risk
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
Module 2: AZD0466 3600 mg+ Voriconazole
n=2 participants at risk
Participants received IV infusion of AZD0466 both with and without voriconazole in Cycle 1. Participants received AZD0466 alone from Cycle 2 (28 days) onwards and beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Rash pustular
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
75.0%
3/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
2/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
42.9%
3/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
2/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
2/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
2/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
30.0%
3/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
28.6%
2/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
5/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
2/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
75.0%
3/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Cardiac disorders
Tachycardia
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
28.6%
2/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
40.0%
2/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
28.6%
2/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
40.0%
2/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
30.0%
3/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Haematemesis
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
28.6%
2/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
40.0%
2/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
30.0%
3/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
66.7%
2/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
2/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
2/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Congenital, familial and genetic disorders
Antithrombin III deficiency
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Asthenia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
28.6%
2/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
60.0%
3/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
2/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Chills
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Fatigue
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
42.9%
3/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Pain
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Pyrexia
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
57.1%
4/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
30.0%
3/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Swelling face
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
60.0%
3/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
2/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Amylase increased
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Aspartate aminotransferase increased
|
75.0%
3/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
60.0%
3/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
2/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
2/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood creatine phosphokinase decreased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
2/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
2/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Coagulation test abnormal
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Electrocardiogram QT shortened
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Gamma-glutamyltransferase increased
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
2/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Lipase increased
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
2/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
40.0%
2/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
30.0%
3/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Protein total decreased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Red blood cell sedimentation rate
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Troponin increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
14.3%
1/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
20.0%
1/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
1/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
10.0%
1/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Citrobacter sepsis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
75.0%
3/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Facial pain
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Infusion site extravasation
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
General disorders
Malaise
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
33.3%
1/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Liver function test abnormal
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
2/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
2/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Troponin I increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
50.0%
1/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
Weight increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
100.0%
2/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/7 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/5 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/10 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/1 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/3 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
25.0%
1/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/4 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
0.00%
0/2 • From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
- Publication restrictions are in place
Restriction type: OTHER