Trial Outcomes & Findings for The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour. (NCT NCT02430311)
NCT ID: NCT02430311
Last Updated: 2019-07-31
Results Overview
Single dose PK parameter summary for olaparib in monotherapy by dose - Cmax (PK analysis set)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Results posted on
2019-07-31
Participant Flow
This study was performed at 3 study centres in China.The first patient entered the study on 10 June 2015 and the last patient completed Part A of the study on 02 August 2016, and the date of last patient last visit in Part B was 28 April 2017.
47 patients were screened in the study. 11 patients were not assigned to treatment due to eligibility criteria not fulfilled. 5 patients excluded from the PK analysis set due to previous gastric surgery. 1 of the 5 patients was also excluded due to vomiting within 3 hours of dosing on a PK day or on the 3 days prior to a multiple dose PK Day.
Participant milestones
| Measure |
Cohort 1
Olaparib 300 mg alone
|
Cohort 2
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Part A
STARTED
|
20
|
16
|
|
Part A
Received Olaparib
|
20
|
16
|
|
Part A
Received Paclitaxel
|
0
|
16
|
|
Part A
COMPLETED
|
19
|
15
|
|
Part A
NOT COMPLETED
|
1
|
1
|
|
Part B
STARTED
|
19
|
15
|
|
Part B
Received Olaparib
|
19
|
15
|
|
Part B
Received Paclitaxel
|
0
|
14
|
|
Part B
COMPLETED
|
9
|
7
|
|
Part B
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
Cohort 1
Olaparib 300 mg alone
|
Cohort 2
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Part A
Adverse Event
|
0
|
1
|
|
Part A
Withdrawal by Subject
|
1
|
0
|
|
Part B
Meet study-specific withdrawal criteria
|
6
|
6
|
|
Part B
Withdrawal by Subject
|
2
|
2
|
|
Part B
Adverse Event
|
1
|
0
|
|
Part B
Death
|
1
|
0
|
Baseline Characteristics
The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=20 Participants
Olaparib 300 mg alone
|
Cohort 2
n=16 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 9.49 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
|
Age, Customized
<50 years
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Customized
≥50 <65 years
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Customized
≥65 <75 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
≥75 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Height
|
164.9 cm
STANDARD_DEVIATION 6.25 • n=5 Participants
|
160.3 cm
STANDARD_DEVIATION 4.81 • n=7 Participants
|
162.8 cm
STANDARD_DEVIATION 6.04 • n=5 Participants
|
|
Weight
|
64.8 kg
STANDARD_DEVIATION 10.35 • n=5 Participants
|
60.9 kg
STANDARD_DEVIATION 8.71 • n=7 Participants
|
63.1 kg
STANDARD_DEVIATION 9.71 • n=5 Participants
|
|
Body mass index
|
23.91 kg/m2
STANDARD_DEVIATION 4.144 • n=5 Participants
|
23.78 kg/m2
STANDARD_DEVIATION 3.599 • n=7 Participants
|
23.85 kg/m2
STANDARD_DEVIATION 3.857 • n=5 Participants
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Single dose PK parameter summary for olaparib in monotherapy by dose - Cmax (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=16 Participants
Olaparib 300 mg alone
|
Cohort 2
n=15 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Single Dose PK Parameter--Cmax
|
6.875 µg/mL
Geometric Coefficient of Variation 39.70
|
2.972 µg/mL
Geometric Coefficient of Variation 41.80
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Single dose PK parameter summary for olaparib in monotherapy by dose - AUC (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=16 Participants
Olaparib 300 mg alone
|
Cohort 2
n=15 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Single Dose PK Parameter--AUC
AUC0-12
|
31.68 µg*h/mL
Geometric Coefficient of Variation 52.97
|
10.86 µg*h/mL
Geometric Coefficient of Variation 61.60
|
|
Single Dose PK Parameter--AUC
AUC0-t
|
36.37 µg*h/mL
Geometric Coefficient of Variation 59.58
|
12.63 µg*h/mL
Geometric Coefficient of Variation 75.42
|
|
Single Dose PK Parameter--AUC
AUC
|
36.53 µg*h/mL
Geometric Coefficient of Variation 59.86
|
12.75 µg*h/mL
Geometric Coefficient of Variation 76.70
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Single dose PK parameter summary for olaparib in monotherapy by dose - tmax (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
n=16 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Single Dose PK Parameter--tmax
|
1.95 hour
Full Range 61.60 • Interval 0.98 to 4.0
|
1.50 hour
Interval 0.5 to 4.0
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Single dose PK parameter summary for olaparib in monotherapy by dose - t1/2, λz (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
n=16 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Single Dose PK Parameter--t1/2, λz
|
7.165 hour
Standard Deviation 2.542 • Interval 3.6 to 11.5
|
6.519 hour
Standard Deviation 1.346 • Interval 4.62 to 8.82
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Single dose PK parameter summary for olaparib in monotherapy by dose - Vz/F (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
n=16 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Single Dose PK Parameter--Vz/F
|
88.32 L
Standard Deviation 44.04 • Interval 3.6 to 11.5
|
74.78 L
Standard Deviation 75.41
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Single dose PK parameter summary for olaparib in monotherapy by dose - CL/F (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
n=16 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Single Dose PK Parameter--CL/F
|
9.217 L/h
Standard Deviation 4.531 • Interval 3.6 to 11.5
|
8.107 L/h
Standard Deviation 6.689
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - Cmax, ss and Cmin, ss (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
n=15 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 8
Cmax, ss
|
8.268 µg/mL
Geometric Coefficient of Variation 35.02
|
3.752 µg/mL
Geometric Coefficient of Variation 40.99
|
|
Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 8
Cmin, ss
|
0.7996 µg/mL
Geometric Coefficient of Variation 117.8
|
0.3162 µg/mL
Geometric Coefficient of Variation 129.4
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - AUC (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
n=15 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Steady State PK Parameter--AUCss at Day 8
AUC0-t
|
43.91 µg*h/mL
Geometric Coefficient of Variation 48.47
|
16.68 µg*h/mL
Geometric Coefficient of Variation 61.30
|
|
Steady State PK Parameter--AUCss at Day 8
AUCss
|
43.95 µg*h/mL
Geometric Coefficient of Variation 48.43
|
16.73 µg*h/mL
Geometric Coefficient of Variation 61.38
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - tmax, ss (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
n=15 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Steady State PK Parameter--tmax, ss at Day 8
|
1.50 hour
Interval 0.97 to 3.0
|
2.00 hour
Interval 0.97 to 4.02
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - RAC and TCP (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
n=15 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Steady State PK Parameter--RAC and TCP at Day 8
RAC
|
1.436 Ratio
Standard Deviation 0.2081
|
1.565 Ratio
Standard Deviation 0.2984
|
|
Steady State PK Parameter--RAC and TCP at Day 8
TCP
|
1.253 Ratio
Standard Deviation 0.2150
|
1.349 Ratio
Standard Deviation 0.3349
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - Cmax, ss and Cmin, ss (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 9
Cmax, ss
|
3.031 µg/mL
Geometric Coefficient of Variation 56.14
|
—
|
|
Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 9
Cmin, ss
|
0.1915 µg/mL
Geometric Coefficient of Variation 125.2
|
—
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - AUC (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Steady State PK Parameter--AUCss at Day 9
AUCss
|
12.44 µg*h/mL
Geometric Coefficient of Variation 57.46
|
—
|
|
Steady State PK Parameter--AUCss at Day 9
AUC0-t
|
12.42 µg*h/mL
Geometric Coefficient of Variation 57.36
|
—
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - tmax, ss (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Steady State PK Parameter--tmax, ss at Day 9
|
1.48 hour
Full Range 61.38 • Interval 0.28 to 5.95
|
—
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8Population: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - CLss/F (PK analysis set)
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Olaparib 300 mg alone
|
Cohort 2
n=15 Participants
Olaparib 100 mg bd in combination with paclitaxel
|
|---|---|---|
|
Steady State PK Parameter--CLss/F at Day 8
|
7.512 L/h
Standard Deviation 3.418
|
6.745 L/h
Standard Deviation 2.923
|
Adverse Events
Cohort 1 Part A
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 2 Part A, Olaparib 100 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2 Part A, Olaparib 100mg in Combination With Paclitaxel
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort 1 Part B
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 2 Part B, Olaparib 300 mg Monotherapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2 Part B, Olaparib 100mg in Combination With Paclitaxel
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Part A
n=20 participants at risk
Part A Olaparib 300 mg alone
|
Cohort 2 Part A, Olaparib 100 mg
n=16 participants at risk
Part A Cohort 2 patients, who have received olaparib 100 mg monotherapy treatment
|
Cohort 2 Part A, Olaparib 100mg in Combination With Paclitaxel
n=16 participants at risk
Part A Cohort 2 patients, who have received olaparib 100 mg + paclitaxel treatment
|
Cohort 1 Part B
n=19 participants at risk
Part B Olaparib 300 mg alone
|
Cohort 2 Part B, Olaparib 300 mg Monotherapy
n=2 participants at risk
Part B Cohort 2 patients, who continued on Olaparib 300mg monotherapy after completed combination therapy
|
Cohort 2 Part B, Olaparib 100mg in Combination With Paclitaxel
n=15 participants at risk
Part B Cohort 2 patients, who have received olaparib 100 mg + paclitaxel treatment
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
18.8%
3/16 • Number of events 3 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Number of events 1 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Number of events 1 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
Other adverse events
| Measure |
Cohort 1 Part A
n=20 participants at risk
Part A Olaparib 300 mg alone
|
Cohort 2 Part A, Olaparib 100 mg
n=16 participants at risk
Part A Cohort 2 patients, who have received olaparib 100 mg monotherapy treatment
|
Cohort 2 Part A, Olaparib 100mg in Combination With Paclitaxel
n=16 participants at risk
Part A Cohort 2 patients, who have received olaparib 100 mg + paclitaxel treatment
|
Cohort 1 Part B
n=19 participants at risk
Part B Olaparib 300 mg alone
|
Cohort 2 Part B, Olaparib 300 mg Monotherapy
n=2 participants at risk
Part B Cohort 2 patients, who continued on Olaparib 300mg monotherapy after completed combination therapy
|
Cohort 2 Part B, Olaparib 100mg in Combination With Paclitaxel
n=15 participants at risk
Part B Cohort 2 patients, who have received olaparib 100 mg + paclitaxel treatment
|
|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
12.5%
2/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
50.0%
8/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
26.3%
5/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
13.3%
2/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
General disorders
Asthenia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
General disorders
Influenza like illness
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
13.3%
2/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
General disorders
Malaise
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
13.3%
2/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
12.5%
2/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
15.8%
3/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
26.7%
4/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
18.8%
3/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
21.1%
4/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
33.3%
5/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
10.5%
2/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
33.3%
5/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
10.5%
2/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
18.8%
3/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
53.3%
8/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
10.5%
2/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
13.3%
2/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
10.5%
2/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
12.5%
2/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
31.2%
5/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
21.1%
4/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
13.3%
2/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
12.5%
2/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
12.5%
2/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
15.8%
3/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
26.7%
4/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
13.3%
2/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
56.2%
9/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
25.0%
4/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
33.3%
5/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
12.5%
2/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
20.0%
3/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Weight decreased
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
12.5%
2/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
10.5%
2/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Blood potassium increased
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Haemoglobin decreased
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
10.5%
2/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Platelet count decreased
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.0%
3/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
75.0%
12/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
42.1%
8/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
50.0%
1/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
100.0%
15/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
68.8%
11/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
42.1%
8/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
50.0%
1/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
93.3%
14/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.0%
3/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
12.5%
2/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
37.5%
6/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
36.8%
7/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
50.0%
1/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
46.7%
7/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.0%
3/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.2%
1/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
10.5%
2/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
15.8%
3/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
20.0%
3/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
General disorders
Peripheral swelling
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
13.3%
2/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
General disorders
Axillary pain
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
General disorders
Chest pain
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
General disorders
Oedema peripheral
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Device related infection
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
13.3%
2/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
10.5%
2/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Lung infection
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Protein urine present
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
10.5%
2/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Investigations
Weight increased
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
6.7%
1/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/20 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/16 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
5.3%
1/19 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/2 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
0.00%
0/15 • Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Principal Investigator may use the Study results (data generated at the site) and shall not publish or present any such results until the earlier of (i) the date of the first Study results publication and (ii) the end of the eighteen (18) month period following the completion, or early termination, of the Study at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER