Trial Outcomes & Findings for A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers. (NCT NCT03907969)
NCT ID: NCT03907969
Last Updated: 2024-02-06
Results Overview
Safety and tolerability of AZD7648 when given orally to patients with advanced malignancies, as monotherapy and in combination with anti-cancer agents was assessed.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
From Screening (Day -28) till study drug discontinuation (3.2 years)
Results posted on
2024-02-06
Participant Flow
A total of 30 patients were enrolled at two sites in the United States and three sites in the United Kingdom from 09 October 2019 to 07 December 2022.
Patients who met the inclusion and none of the exclusion criteria were enrolled to the study. This study consisted of a screening period of 28 days. All the study assessments were performed as per schedule of assessment.
Participant milestones
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Monotherapy Part A
STARTED
|
1
|
1
|
1
|
1
|
3
|
4
|
3
|
0
|
0
|
0
|
0
|
|
Monotherapy Part A
COMPLETED
|
1
|
0
|
0
|
0
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Monotherapy Part A
NOT COMPLETED
|
0
|
1
|
1
|
1
|
1
|
3
|
2
|
0
|
0
|
0
|
0
|
|
Combination Therapy Part A
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
5
|
7
|
|
Combination Therapy Part A
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Combination Therapy Part A
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
4
|
6
|
Reasons for withdrawal
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Monotherapy Part A
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Monotherapy Part A
Progressive Disease
|
0
|
1
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Monotherapy Part A
Death
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Combination Therapy Part A
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Combination Therapy Part A
Progressive disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
3
|
|
Combination Therapy Part A
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Combination Therapy Part A
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Combination Therapy Part A
Other than specified main reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Combination Therapy Part A
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers.
Baseline characteristics by cohort
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 Participants
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=3 Participants
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=4 Participants
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 Participants
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=2 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=5 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
n=7 Participants
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
|
NA Years
STANDARD_DEVIATION NA • n=5 Participants
|
NA Years
STANDARD_DEVIATION NA • n=7 Participants
|
NA Years
STANDARD_DEVIATION NA • n=5 Participants
|
NA Years
STANDARD_DEVIATION NA • n=4 Participants
|
64.3 Years
STANDARD_DEVIATION 6.35 • n=21 Participants
|
60.3 Years
STANDARD_DEVIATION 8.18 • n=10 Participants
|
51.3 Years
STANDARD_DEVIATION 2.08 • n=115 Participants
|
NA Years
STANDARD_DEVIATION NA • n=6 Participants
|
NA Years
STANDARD_DEVIATION NA • n=6 Participants
|
56.6 Years
STANDARD_DEVIATION 10.16 • n=64 Participants
|
61.7 Years
STANDARD_DEVIATION 16.18 • n=17 Participants
|
60.20 Years
STANDARD_DEVIATION 10.20 • n=21 Participants
|
|
Sex/Gender, Customized
All
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
11 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
4 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
15 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
5 Participants
n=17 Participants
|
16 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From Screening (Day -28) till study drug discontinuation (3.2 years)Population: All patients who received at least 1 dose of any study treatment.
Safety and tolerability of AZD7648 when given orally to patients with advanced malignancies, as monotherapy and in combination with anti-cancer agents was assessed.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 Participants
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=3 Participants
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=4 Participants
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 Participants
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=2 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=5 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
n=7 Participants
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE leading to AZD7648 dose modification
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE possibly related to AZD7648
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE possibly related to PLD
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE of CTCAE Grade 3 or higher
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE of CTCAE Grade 3 or higher, possibly related to AZD7648
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE of CTCAE Grade 3 or higher, possibly related to PLD
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE with outcome of death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE with outcome of death, possibly related to AZD7648
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE with outcome of death, possibly related to PLD
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any SAE, possibly related to AZD7648
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any SAE, possibly related to PLD
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any SAE with outcome of death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any SAE with outcome of death, possibly related to AZD7648
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any SAE with outcome of death, possibly related to PLD
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any SAE causing discontinuation of AZD7648
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any SAE causing discontinuation of AZD7648, possibly related to AZD7648
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any SAE causing discontinuation of AZD7648, possibly related to PLD
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE leading to discontinuation of AZD7648
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE leading to discontinuation of PLD
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE leading to AZD7648 dose reduction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE leading to PLD dose reduction
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE leading to AZD7648 dose interruption
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE leading to PLD dose interruption
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events or Serious Adverse Events
Any AE leading to PLD dose modification
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From Screening (Day -28) till study drug discontinuation (3.2 years)Population: All patients who received at least 1 dose of any study treatment.
A DLT is defined as an AE that occurs from the first dose of study treatment up to and including Cycle 1, Day 28 (the DLT assessment period) that is assessed as unrelated to the disease, intercurrent illness, or concomitant medications.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 Participants
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=3 Participants
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=4 Participants
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 Participants
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=2 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=4 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
n=7 Participants
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Monotherapy and Combination therapy: Cycle 0 Day 1 Pre-dose to 72 hours post-dose [each cycle is 28 days]Population: All patients who received at least 1 dose of any study treatment and had at least 1 reportable post first dose concentration without any protocol deviations that might have affected pharmacokinetic (PK).
The AUCinf of AZD7648, following a single dose and at steady state after multiple dosing, when given orally as monotherapy and in combination with anti-cancer agents.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 Participants
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=1 Participants
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=3 Participants
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 Participants
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=2 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=4 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
n=7 Participants
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under Plasma Concentration-time Curve From Zero to Infinity (AUCinf)
|
NA h*nmol/L
Standard Deviation NA
Mean cannot be calculated due to low number participant.
|
NA h*nmol/L
Standard Deviation NA
Mean cannot be calculated due to low number participant.
|
NA h*nmol/L
Standard Deviation NA
Mean cannot be calculated due to low number participant.
|
NA h*nmol/L
Standard Deviation NA
Mean cannot be calculated due to low number participant.
|
NA h*nmol/L
Standard Deviation NA
Mean cannot be calculated due to low number participant.
|
25180 h*nmol/L
Standard Deviation 48.76
|
29680 h*nmol/L
Standard Deviation 19.72
|
NA h*nmol/L
Standard Deviation NA
Mean cannot be calculated due to low number participant.
|
NA h*nmol/L
Standard Deviation NA
Mean cannot be calculated due to low number participant.
|
3826 h*nmol/L
Standard Deviation 55.72
|
5539 h*nmol/L
Standard Deviation 52.04
|
SECONDARY outcome
Timeframe: Monotherapy and Combination therapy: Cycle 0 Day 1 Pre-dose to 72 hours post-dose (each cycle is 28 days)Population: All patients who received at least 1 dose of any study treatment and had at least 1 reportable post first dose concentration without any protocol deviations that might have affected PK.
The AUClast of AZD7648, following a single dose, when given orally as monotherapy and in combination with anti-cancer agents.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 Participants
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=2 Participants
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=3 Participants
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 Participants
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=2 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=4 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
n=7 Participants
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-curve From Zero to the Last Quantifiable Concentration (AUClast)
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
24940 h*nmol/L
Geometric Coefficient of Variation 49.04
|
29540 h*nmol/L
Geometric Coefficient of Variation 19.64
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
3798 h*nmol/L
Geometric Coefficient of Variation 55.78
|
5509 h*nmol/L
Geometric Coefficient of Variation 52.19
|
SECONDARY outcome
Timeframe: Monotherapy and Combination therapy: Cycle 0 Day 1 Pre-dose to 72 hours post-dose (each cycle is 28 days)Population: All patients who received at least 1 dose of any study treatment and had at least 1 reportable post first dose concentration without any protocol deviations that might have affected PK.
The AUCτ of AZD7648, at steady state after multiple dosing, when given orally as monotherapy and in combination with anti-cancer agents.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=1 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=1 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under Plasma Concentration-time Curve in the Dosing Interval τ (AUCτ)
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
—
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
—
|
—
|
—
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participants.
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participants.
|
NA h*nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participants.
|
—
|
SECONDARY outcome
Timeframe: Monotherapy: Cycle 0 Day 1 Pre-dose to 72 hours post-dose, Cycle 1 Day 8 Pre-dose to 12 hours post dose; Combination therapy: Cycle 0 Day 1 Pre-dose to 12 hours post dose and Cycle 1 Days 7, 8 Pre-dose to 8 hours post dose (each cycle is 28 days)Population: All patients who received at least 1 dose of any study treatment and had at least 1 reportable post first dose concentration without any protocol deviations that might have affected PK.
The Cmax of AZD7648, following a single dose and at steady state after multiple dosing, when given orally as monotherapy and in combination with anti-cancer agents.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 Participants
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=2 Participants
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=3 Participants
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 Participants
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=2 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=4 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
n=7 Participants
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma (Peak) Drug Concentration After Single Dose and Multiple Doses (Cmax)
Cycle 0 Day 1
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
2463 nmol/L
Geometric Coefficient of Variation 56.72
|
4026 nmol/L
Geometric Coefficient of Variation 13.97
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
376.8 nmol/L
Geometric Coefficient of Variation 27.66
|
754.2 nmol/L
Geometric Coefficient of Variation 34.29
|
|
Maximum Observed Plasma (Peak) Drug Concentration After Single Dose and Multiple Doses (Cmax)
Cycle 1 Day 7 Cycle 1 Day 8
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
5426 nmol/L
Geometric Coefficient of Variation 12.75
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
—
|
NA nmol/L
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
944.9 nmol/L
Geometric Coefficient of Variation 62.85
|
SECONDARY outcome
Timeframe: Monotherapy: Cycle 0 Day 1 Pre-dose to 72 hours post-dose, Cycle 1 Day 8 Pre-dose to 12 hours post dose; Combination therapy: Cycle 0 Day 1 Pre-dose to 12 hours post dose and Cycle 1 Days 7, 8 Pre-dose to 8 hours post dose (each cycle is 28 days)Population: All patients who received at least 1 dose of any study treatment and had at least 1 reportable post first dose concentration without any protocol deviations that might have affected PK.
The tmax of AZD7648, following a single dose and at steady state after multiple dosing, when given orally as monotherapy and in combination with anti-cancer agents.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 Participants
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=2 Participants
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=3 Participants
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 Participants
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=2 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=5 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
n=7 Participants
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
Cycle 0 Day 1
|
NA Hours
Interval 1.08 to 1.08
Median cannot be calculated due to low number participants.
|
NA Hours
Interval 2.17 to 2.17
Median cannot be calculated due to low number participants.
|
NA Hours
Interval 1.0 to 1.0
Median cannot be calculated due to low number participants.
|
NA Hours
Interval 1.03 to 1.03
Median cannot be calculated due to low number participants.
|
NA Hours
Interval 2.07 to 9.0
Median cannot be calculated due to low number participants.
|
2.050 Hours
Interval 2.03 to 2.13
|
2.033 Hours
Interval 1.08 to 2.07
|
NA Hours
Interval 1.07 to 2.08
Median cannot be calculated due to low number participants.
|
NA Hours
Interval 1.08 to 2.08
Median cannot be calculated due to low number participants.
|
3.058 Hours
Interval 1.95 to 8.07
|
1.150 Hours
Interval 0.68 to 2.17
|
|
Time to Reach Maximum Plasma Concentration (Tmax)
Cycle 1 Day 7 Cycle 1 Day 8
|
NA Hours
Interval 1.12 to 1.12
Median cannot be calculated due to low number participants.
|
NA Hours
Interval 2.07 to 2.07
Median cannot be calculated due to low number participants.
|
NA Hours
Interval 1.05 to 1.05
Median cannot be calculated due to low number participants.
|
NA Hours
Interval 2.0 to 2.0
Median cannot be calculated due to low number participants.
|
NA Hours
Interval 2.0 to 2.0
Median cannot be calculated due to low number participants.
|
NA Hours
Interval 2.07 to 2.15
Median cannot be calculated due to low number participants.
|
2.167 Hours
Interval 2.1 to 2.42
|
NA Hours
Interval 1.08 to 2.0
Median cannot be calculated due to low number participants.
|
—
|
NA Hours
Interval 2.03 to 2.03
Median cannot be calculated due to low number participants.
|
1.100 Hours
Interval 1.0 to 2.2
|
SECONDARY outcome
Timeframe: Monotherapy and Combination therapy: Cycle 0 Day 1 Pre-dose to 72 hours post-dose (each cycle is 28 days)Population: All patients who received at least 1 dose of any study treatment and had at least 1 reportable post first dose concentration without any protocol deviations that might have affected PK.
The t½λ of AZD7648, following a single dose and at steady state after multiple dosing, when given orally as monotherapy and in combination with anti-cancer agents.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 Participants
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=1 Participants
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=3 Participants
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 Participants
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=2 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=4 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
n=7 Participants
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz)
|
NA Hours
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA Hours
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA Hours
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA Hours
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA Hours
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
10.32 Hours
Geometric Coefficient of Variation 39.41
|
10.64 Hours
Geometric Coefficient of Variation 27.39
|
NA Hours
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participants.
|
NA Hours
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participants.
|
6.506 Hours
Geometric Coefficient of Variation 44.51
|
7.562 Hours
Geometric Coefficient of Variation 51.64
|
SECONDARY outcome
Timeframe: Monotherapy: Cycle 1 Day 8 Pre-dose to 12 hours post dose; Combination therapy: Cycle 1 Days 7 and 8 Pre-dose to 8 hours post dose (each cycle is 28 days)Population: All patients who received at least 1 dose of any study treatment and had at least 1 reportable post first dose concentration without any protocol deviations that might have affected PK.
The Rac AUC of AZD7648, following a single dose and at steady state after multiple dosing, when given orally as monotherapy and in combination with anti-cancer agents. Accumulation ratio for AUC, calculated by multiple dose AUCτ/single dose AUC(0-12) or AUC(0-24).
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=1 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=1 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio for Area Under Curve (Rac AUC)
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
—
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
—
|
—
|
—
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participants.
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
—
|
SECONDARY outcome
Timeframe: Monotherapy: Cycle 1 Day 8 Pre-dose to 12 hours post dose; Combination therapy: Cycle 1 Days 7 and 8 Pre-dose to 8 hours post dose (each cycle is 28 days)Population: All patients who received at least 1 dose of any study treatment and had at least 1 reportable post first dose concentration without any protocol deviations that might have affected PK.
The Rac Cmax of AZD7648, following a single dose and at steady state after multiple dosing, when given orally as monotherapy and in combination with anti-cancer agents. Accumulation ratio for Cmax, calculated by multiple dose Cmax/single dose Cmax.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=1 Participants
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=2 Participants
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 Participants
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=1 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=5 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio for Cmax (Rac Cmax)
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
—
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participants.
|
1.348 Ratio
Geometric Coefficient of Variation 1.272
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participants.
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participants.
|
1.157 Ratio
Geometric Coefficient of Variation 23.99
|
—
|
SECONDARY outcome
Timeframe: Monotherapy: Cycle 1 Day 8 Pre-dose to 12 hours post dose; Combination therapy: Cycle 1 Days 7 and 8 Pre-dose to 8 hours post dose (each cycle is 28 days)Population: All patients who received at least 1 dose of any study treatment and had at least 1 reportable post first dose concentration without any protocol deviations that might have affected PK.
The TCP of AZD7648, following a single dose and at steady state after multiple dosing, when given orally as monotherapy and in combination with anti-cancer agents. Temporal change parameter in systemic exposure, calculated as multiple dose AUCtau/single dose AUCinf.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=1 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=1 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Proportionality (TCP)
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
—
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
—
|
—
|
—
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participants.
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
NA Ratio
Geometric Coefficient of Variation NA
Mean cannot be calculated due to low number participant.
|
—
|
SECONDARY outcome
Timeframe: First dose of study treatment on Cycle 1 Day 1 (each cycle is 28 days) until progression or the last evaluable assessment in the absence of progression (3.2 years)Population: Evaluable for objective response set included all patients who had a measurable baseline disease (having at least one measurable target lesion, not previously irradiated, which is ≥ 10 mm in the longest diameter (LD) (except lymph nodes which must have short axis ≥ 15 mm) by RECIST 1.1 assessment and received at least one dose of any study treatment.
ORR is defined as the percentage of patients who have a confirmed visit response of complete response (CR) or partial response (PR) prior to any evidence of progression (as defined by Response Evaluation Criteria in Solid Tumours 1.1). CR is defined when all target lesions (TLs) and non-target lesions (NTLs) present at baseline have disappeared (with the exception of lymph nodes which must be \<10mm to be considered non pathological) and no new lesions have developed since baseline. PR is defined when the sum of diameters of the TLs has decreased by 30% or more compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 Participants
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=2 Participants
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=4 Participants
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=2 Participants
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 Participants
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=2 Participants
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=5 Participants
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
n=6 Participants
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
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
|
50 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Evaluable for efficacy set included all patients who received at least 1 dose of any study treatment and have a baseline tumour assessment according to RECIST 1.1.
PFS is defined as the time from first dose of Cycle 1 until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from study therapy or receives another anti-cancer therapy prior to progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as increased by \> 20% or more compared to the smallest sum of diameters on study.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 Participants
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=3 Participants
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=4 Participants
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 Participants
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) for Monotherapy
|
NA Months
Median cannot be calculated due low number of participant.
|
NA Months
Median cannot be calculated due low number of participant.
|
NA Months
Median cannot be calculated due low number of participant.
|
NA Months
Median cannot be calculated due low number of participant.
|
1.91 Months
Interval 1.71 to 3.42
|
2.50 Months
Interval 1.64 to 3.52
|
1.51 Months
Interval 1.05 to 7.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 18 monthsPopulation: Evaluable for efficacy set included all patients who received at least 1 dose of any study treatment and have a baseline tumour assessment according to RECIST 1.1.
PFS is defined as the time from first dose of Cycle 1 until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from study therapy or receives another anti-cancer therapy prior to progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as increased by \> 20% or more compared to the smallest sum of diameters on study.
Outcome measures
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=2 Participants
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=2 Participants
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=5 Participants
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=7 Participants
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) for Combination Therapy
|
NA Months
Median cannot be calculated due low number of participants.
|
NA Months
Median cannot be calculated due low number of participants.
|
1.74 Months
Interval 1.66 to 1.84
|
2.07 Months
Interval 1.87 to 4.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1: AZD7648 Dose A (Monotherapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: AZD7648 Dose A1 (Monotherapy)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: AZD7648 Dose B1 (Monotherapy)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Cohort 4: AZD7648 Dose C1 (Monotherapy)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Cohort 5: AZD7648 Dose D1 (Monotherapy)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Cohort 6: AZD7648 Dose E1 (Monotherapy)
Serious events: 4 serious events
Other events: 4 other events
Deaths: 1 deaths
Cohort 7: AZD7648 Dose F1 (Monotherapy)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 participants at risk
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 participants at risk
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 participants at risk
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 participants at risk
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=3 participants at risk
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=4 participants at risk
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 participants at risk
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 participants at risk
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=2 participants at risk
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=5 participants at risk
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
n=7 participants at risk
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Infection
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
—
0/0 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Injury, poisoning and procedural complications
Post procedural pulmonary embolism
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
Other adverse events
| Measure |
Cohort 1: AZD7648 Dose A (Monotherapy)
n=1 participants at risk
Patients received single dose A of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 2: AZD7648 Dose A1 (Monotherapy)
n=1 participants at risk
Patients received single dose A1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose A of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 3: AZD7648 Dose B1 (Monotherapy)
n=1 participants at risk
Patients received single dose B1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose B1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 4: AZD7648 Dose C1 (Monotherapy)
n=1 participants at risk
Patients received single dose C1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose C1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 5: AZD7648 Dose D1 (Monotherapy)
n=3 participants at risk
Patients received single dose D1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose D1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 6: AZD7648 Dose E1 (Monotherapy)
n=4 participants at risk
Patients received single dose E1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose E1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 7: AZD7648 Dose F1 (Monotherapy)
n=3 participants at risk
Patients received single dose F1 of AZD7648, and after a washout period patients received multiple continuous dosing of dose F1 of AZD7648 in 28-day cycle regimen orally on an empty stomach.
|
Cohort 1: AZD7648 Dose C1 + PLD (Combination Therapy)
n=2 participants at risk
Patients received continuous dosing of dose C1 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by intravenous (IV) infusion once every 4 weeks.
|
Cohort 1: AZD7648 Dose C + PLD (Combination Therapy)
n=2 participants at risk
Patients received single dosing of dose C of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 2: AZD7648 Dose C2 + PLD (Combination Therapy)
n=5 participants at risk
Patients received single dosing of dose C2 of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
Cohort 3: AZD7648 Dose X + PLD (Combination Therapy)
n=7 participants at risk
Patients received single dosing of dose X of AZD7648 orally on an empty stomach. In combination of AZD7648 patients also received PLD of 40 mg/m\^2, administered by IV infusion once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
28.6%
2/7 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
40.0%
2/5 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
66.7%
2/3 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
40.0%
2/5 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
7/7 • Number of events 9 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
2/2 • Number of events 9 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
42.9%
3/7 • Number of events 3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
2/2 • Number of events 7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
66.7%
2/3 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
20.0%
1/5 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
42.9%
3/7 • Number of events 4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
20.0%
1/5 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Eye disorders
Visual impairment
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
66.7%
2/3 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
28.6%
2/7 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
20.0%
1/5 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
66.7%
2/3 • Number of events 3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
40.0%
2/5 • Number of events 4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
57.1%
4/7 • Number of events 6 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
2/2 • Number of events 3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
40.0%
2/5 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
28.6%
2/7 • Number of events 3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
2/4 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
20.0%
1/5 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
General disorders
Fatigue
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
2/2 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
60.0%
3/5 • Number of events 4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
42.9%
3/7 • Number of events 3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
General disorders
Pyrexia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Investigations
Weight decreased
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
25.0%
1/4 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
33.3%
1/3 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Candida infection
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Groin abscess
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
28.6%
2/7 • Number of events 3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Infections and infestations
Pleural infection
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
20.0%
1/5 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
20.0%
1/5 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
20.0%
1/5 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
20.0%
1/5 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
General disorders
Catheter site pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
General disorders
Pain
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
2/2 • Number of events 3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
100.0%
2/2 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
20.0%
1/5 • Number of events 2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
14.3%
1/7 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/4 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/3 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
50.0%
1/2 • Number of events 1 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/2 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/5 • From Screening (Day -28) till study drug discontinuation (3.2 years)
|
0.00%
0/7 • From Screening (Day -28) till study drug discontinuation (3.2 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