Trial Outcomes & Findings for Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment (NCT NCT01894243)
NCT ID: NCT01894243
Last Updated: 2019-09-13
Results Overview
Summary of Geometric Least Squares (GLS) Mean for normal, mild and moderate hepatic impairment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.
Results posted on
2019-09-13
Participant Flow
The first patient was enrolled on 13 March 2014 and the last patient was enrolled on 23 January 2015. Patients were enrolled at 8 centers in 3 countries. Of the 31 patients enrolled, 24 were assigned to treatment.
Approximately 30 patients were planned to be enrolled with at least 24 evaluable patients required to complete Part A (8 patients with normal hepatic function, 8 with mild hepatic impairment and 8 with moderate hepatic impairment). An evaluable patient is defined as a patient having full PK sampling to 96 hours post-dose of olaparib
Participant milestones
| Measure |
Normal Hepatic Function
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Impairment
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
8
|
|
Overall Study
Completed Treatment in Part A
|
13
|
10
|
8
|
|
Overall Study
Ongoing Into Part B
|
13
|
10
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
8
|
Reasons for withdrawal
| Measure |
Normal Hepatic Function
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Impairment
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
|
Overall Study
Death
|
0
|
0
|
3
|
|
Overall Study
Lack of Efficacy
|
3
|
3
|
1
|
|
Overall Study
Condition under investigation worsened
|
8
|
6
|
2
|
|
Overall Study
Subject decision
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
0
|
Baseline Characteristics
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
Baseline characteristics by cohort
| Measure |
Normal Hepatic Function
n=13 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=10 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Impairment
n=8 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 8.35 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 10.70 • n=7 Participants
|
67.9 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 9.23 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.Population: PK Analysis Set (Part A) One patient excluded from mild impairment arm due to surgery that may affect olaparib absorption.
Summary of Geometric Least Squares (GLS) Mean for normal, mild and moderate hepatic impairment
Outcome measures
| Measure |
Normal Hepatic Function
n=13 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=9 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Function
n=8 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
7.32 μg/mL
Interval 5.95 to 9.0
|
8.25 μg/mL
Interval 6.43 to 10.58
|
6.40 μg/mL
Interval 4.92 to 8.34
|
PRIMARY outcome
Timeframe: Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.Population: PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.
Summary of ratio of Geometric Least Squares (GLS) Means
Outcome measures
| Measure |
Normal Hepatic Function
n=22 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=21 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Function
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Ratio of Maximum Plasma Concentration (Cmax) - Mild vs Normal and Moderate vs Normal
|
1.13 ratio
Interval 0.82 to 1.56
|
0.87 ratio
Interval 0.63 to 1.22
|
—
|
PRIMARY outcome
Timeframe: Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.Population: PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.
Summary of Geometric Least Squares (GLS) Mean
Outcome measures
| Measure |
Normal Hepatic Function
n=13 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=9 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Function
n=8 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC)
|
52.33 μg*h/mL
Interval 38.88 to 70.43
|
60.25 μg*h/mL
Interval 42.17 to 86.1
|
56.29 μg*h/mL
Interval 38.55 to 82.2
|
PRIMARY outcome
Timeframe: Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.Population: PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.
Summary of Ratio of Geometric Least Squares (GLS) Means
Outcome measures
| Measure |
Normal Hepatic Function
n=22 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=21 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Function
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Ratio of Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC) - Mild vs Normal and Moderate vs Normal
|
1.15 ratio
Interval 0.72 to 1.83
|
1.08 ratio
Interval 0.66 to 1.74
|
—
|
PRIMARY outcome
Timeframe: Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.Population: PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.
Summary of Geometric Least Squares (GLS) Mean for ratio of mild hepatic impairment compared to normal
Outcome measures
| Measure |
Normal Hepatic Function
n=13 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=9 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Function
n=8 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Zero to the Last Measureable Time Point(AUC 0-t)
|
51.82 μg*h/mL
Interval 38.69 to 69.4
|
59.64 μg*h/mL
Interval 41.99 to 84.73
|
55.97 μg*h/mL
Interval 38.57 to 81.22
|
PRIMARY outcome
Timeframe: Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.Population: PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.
Summary of Ratio of Geometric Least Squares (GLS) Means
Outcome measures
| Measure |
Normal Hepatic Function
n=22 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=21 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Function
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Ratio of Area Under the Plasma Concentration Time Curve From Zero to the Last Measureable Time Point(AUC 0-t)
|
1.15 ratio
Interval 0.73 to 1.82
|
1.08 ratio
Interval 0.67 to 1.73
|
—
|
PRIMARY outcome
Timeframe: Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.Population: PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.
Summary of Geometric Least Squares (GLS) Means
Outcome measures
| Measure |
Normal Hepatic Function
n=13 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=9 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Function
n=8 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Apparent Clearance Following Oral Administration (CL/F)
|
5.73 L/hr
Interval 4.26 to 7.72
|
4.98 L/hr
Interval 3.48 to 7.11
|
5.33 L/hr
Interval 3.65 to 7.78
|
PRIMARY outcome
Timeframe: Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.Population: PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.
Summary of Ratio of Geometric Least Squares (GLS) Means
Outcome measures
| Measure |
Normal Hepatic Function
n=22 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=21 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Function
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Ratio of Apparent Clearance Following Oral Administration (CL/F)
|
0.87 ratio
Interval 0.55 to 1.38
|
0.93 ratio
Interval 0.57 to 1.5
|
—
|
PRIMARY outcome
Timeframe: Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.Population: PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.
Outcome measures
| Measure |
Normal Hepatic Function
n=13 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=9 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Function
n=8 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
|
1.53 h
Interval 0.93 to 6.0
|
2.05 h
Interval 1.5 to 6.08
|
1.54 h
Interval 0.5 to 6.0
|
PRIMARY outcome
Timeframe: Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.Population: PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.
Outcome measures
| Measure |
Normal Hepatic Function
n=13 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=9 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Function
n=8 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Terminal Half-life (t½)
|
17.41 h
Geometric Coefficient of Variation 61.7
|
16.58 h
Geometric Coefficient of Variation 49.6
|
13.70 h
Geometric Coefficient of Variation 37.5
|
PRIMARY outcome
Timeframe: Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.Population: PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.
Outcome measures
| Measure |
Normal Hepatic Function
n=13 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with normal hepatic function
|
Mild Hepatic Impairment
n=9 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with mild hepatic function
|
Moderate Hepatic Function
n=8 Participants
Olaparib 300 mg (2x150 mg tablets) single dose administered to patients with moderate hepatic function
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
144.0 L
Geometric Coefficient of Variation 62.5
|
119.1 L
Geometric Coefficient of Variation 58.7
|
105.4 L
Geometric Coefficient of Variation 84.0
|
Adverse Events
Normal (Part A)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Mild (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Moderate (Part A)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Normal (Part B)
Serious events: 3 serious events
Other events: 13 other events
Deaths: 1 deaths
Mild (Part B)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 1 deaths
Moderate (Part B)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Normal (Part A)
n=13 participants at risk
Normal hepatic function (Part A)
|
Mild (Part A)
n=10 participants at risk
Mild hepatic impairment (Part A)
|
Moderate (Part A)
n=8 participants at risk
Moderate hepatic impairment (Part A)
|
Normal (Part B)
n=13 participants at risk
Normal hepatic function
|
Mild (Part B)
n=10 participants at risk
Mild hepatic impairment (Part B)
|
Moderate (Part B)
n=8 participants at risk
Moderate hepatic impairment (Part B)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
General disorders
Asthenia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Nervous system disorders
Seizure
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
Other adverse events
| Measure |
Normal (Part A)
n=13 participants at risk
Normal hepatic function (Part A)
|
Mild (Part A)
n=10 participants at risk
Mild hepatic impairment (Part A)
|
Moderate (Part A)
n=8 participants at risk
Moderate hepatic impairment (Part A)
|
Normal (Part B)
n=13 participants at risk
Normal hepatic function
|
Mild (Part B)
n=10 participants at risk
Mild hepatic impairment (Part B)
|
Moderate (Part B)
n=8 participants at risk
Moderate hepatic impairment (Part B)
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
25.0%
2/8 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
15.4%
2/13 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
30.0%
3/10 • Number of events 3 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
15.4%
2/13 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
3/13 • Number of events 3 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
20.0%
2/10 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Gastrointestinal disorders
Nausea
|
30.8%
4/13 • Number of events 4 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
53.8%
7/13 • Number of events 7 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
50.0%
5/10 • Number of events 5 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
25.0%
2/8 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
General disorders
Asthenia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
15.4%
2/13 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
20.0%
2/10 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
General disorders
Fatigue
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
46.2%
6/13 • Number of events 6 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
15.4%
2/13 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
20.0%
2/10 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
20.0%
2/10 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
37.5%
3/8 • Number of events 3 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
15.4%
2/13 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
20.0%
2/10 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
15.4%
2/13 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
23.1%
3/13 • Number of events 3 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
37.5%
3/8 • Number of events 3 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
38.5%
5/13 • Number of events 5 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
15.4%
2/13 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
15.4%
2/13 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
15.4%
2/13 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
20.0%
2/10 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
23.1%
3/13 • Number of events 3 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
12.5%
1/8 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
15.4%
2/13 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
23.1%
3/13 • Number of events 3 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
10.0%
1/10 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
7.7%
1/13 • Number of events 1 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
20.0%
2/10 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
15.4%
2/13 • Number of events 2 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/10 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
0.00%
0/8 • Onset date between the date of first dose in Part A and the day before first dose in Part B, or 30 days following the date of last dose of study medication if the subject has discontinued in Part A. For Part B, onset date on or after the first dose in Part B, and up to (and including) 30 days after the last dose date in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60