Trial Outcomes & Findings for Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva) (NCT NCT02157883)
NCT ID: NCT02157883
Last Updated: 2025-11-19
Results Overview
Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.
Results posted on
2025-11-19
Participant Flow
First subject enrolled: 6 November 2014; Last Subject Last Visit Part A: 3 April 2015 and Part B: 31 March 2016. Study performed at 15 sites across Asia, North America and Western Europe. Part A assessed effect of multiple doses of itraconazole on PK of AZD9291; Part B allowed subjects further access to AZD9291 and provided additional safety data.
The 39 patients started Period 1 and received treatment.
Participant milestones
| Measure |
AZD9291 and Itraconozole (Part A); AZD9291 Alone (Part B)
In Part A of the study, sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole. Each patient received single 80 mg oral doses of AZD9291 tablets on Days 1 and 10, and in addition received itraconazole capsules 200 mg twice daily on Days 6 to 18.
In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
|
|---|---|
|
Part A: Day 1-5 (AZD9291 Alone)
STARTED
|
39
|
|
Part A: Day 1-5 (AZD9291 Alone)
COMPLETED
|
38
|
|
Part A: Day 1-5 (AZD9291 Alone)
NOT COMPLETED
|
1
|
|
Part A: Day 6-18 (AZD9291+Itraconozole)
STARTED
|
39
|
|
Part A: Day 6-18 (AZD9291+Itraconozole)
COMPLETED
|
38
|
|
Part A: Day 6-18 (AZD9291+Itraconozole)
NOT COMPLETED
|
1
|
|
Part B: Day 19 to End Part B (AZD9291)
STARTED
|
38
|
|
Part B: Day 19 to End Part B (AZD9291)
COMPLETED
|
16
|
|
Part B: Day 19 to End Part B (AZD9291)
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
AZD9291 and Itraconozole (Part A); AZD9291 Alone (Part B)
In Part A of the study, sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole. Each patient received single 80 mg oral doses of AZD9291 tablets on Days 1 and 10, and in addition received itraconazole capsules 200 mg twice daily on Days 6 to 18.
In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
|
|---|---|
|
Part A: Day 6-18 (AZD9291+Itraconozole)
Adverse Event
|
1
|
|
Part B: Day 19 to End Part B (AZD9291)
Adverse Event
|
3
|
|
Part B: Day 19 to End Part B (AZD9291)
Disease progression
|
15
|
|
Part B: Day 19 to End Part B (AZD9291)
Withdrawal by Subject
|
1
|
|
Part B: Day 19 to End Part B (AZD9291)
Death
|
3
|
Baseline Characteristics
Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva)
Baseline characteristics by cohort
| Measure |
AZD9291 and Itraconozole (Part A); AZD9291 Alone (Part B)
n=39 Participants
In Part A of the study, sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole. Each patient received single 80 mg oral doses of AZD9291 tablets on Days 1 and 10, and in addition received itraconazole capsules 200 mg twice daily on Days 6 to 18.
In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
|
|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 10.73 • n=39 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>10% of Cmax).
Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration
Outcome measures
| Measure |
AZD9291+Itraconazole
n=30 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=34 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
Cmax of AZD9291
|
201.7 nM
Interval 78.2 to 676.0
|
242.5 nM
Interval 88.8 to 704.0
|
PRIMARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>10% of Cmax).
Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to infinity
Outcome measures
| Measure |
AZD9291+Itraconazole
n=30 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=33 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
AUC of AZD9291
|
17090 nM*h
Interval 7130.0 to 59600.0
|
13520 nM*h
Interval 6510.0 to 40400.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>10% of Cmax).
Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours
Outcome measures
| Measure |
AZD9291+Itraconazole
n=31 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=34 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
AUC(0-120) of AZD9291
|
11370 nM*h
Interval 5100.0 to 37500.0
|
10280 nM*h
Interval 4980.0 to 27500.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>10% of Cmax).
Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration curve from time zero to last quantifiable dose
Outcome measures
| Measure |
AZD9291+Itraconazole
n=31 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=34 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
AUC(0-t) of AZD9291
|
14520 nM*h
Interval 6280.0 to 49600.0
|
12260 nM*h
Interval 6090.0 to 33600.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>10% of Cmax).
Pharmacokinetics of AZD9291 by assessment of time to Cmax
Outcome measures
| Measure |
AZD9291+Itraconazole
n=30 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=34 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
Tmax of AZD9291
|
6.04 hours
Interval 3.0 to 72.0
|
4.00 hours
Interval 2.03 to 11.87
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>10% of Cmax).
Pharmacokinetics of AZD9291 by assessment of the terminal half-life
Outcome measures
| Measure |
AZD9291+Itraconazole
n=30 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=34 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
t1/2 of AZD9291
|
78.36 hours
Interval 56.3 to 150.0
|
61.05 hours
Interval 38.7 to 131.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>10% of Cmax).
Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration
Outcome measures
| Measure |
AZD9291+Itraconazole
n=30 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=33 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
CL/F of AZD9291
|
9.368 L/h
Interval 2.69 to 22.5
|
11.84 L/h
Interval 3.96 to 24.6
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>10% of Cmax).
Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution
Outcome measures
| Measure |
AZD9291+Itraconazole
n=30 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=33 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
Vz/F of AZD9291
|
1059 L
Interval 344.0 to 2630.0
|
1019 L
Interval 491.0 to 2310.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose AZ5104 concentration \>20% of Cmax).
Pharmacokinetics of AZ5104 (metabolite to AZD9291) by assessment of maximum plasma AZ5104 concentration
Outcome measures
| Measure |
AZD9291+Itraconazole
n=16 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=34 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
Cmax of AZ5104
|
5.746 nM
Interval 2.15 to 15.8
|
8.568 nM
Interval 2.36 to 23.4
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose AZ5104 concentration \>20% of Cmax).
Pharmacokinetics of AZ5104 (metabolite to AZD9291) by assessment of area under the plasma concentration time curve from zero to infinity
Outcome measures
| Measure |
AZD9291+Itraconazole
n=15 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=31 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
AUC of AZ5104
|
941.4 nM*h
Interval 337.0 to 2620.0
|
1155 nM*h
Interval 367.0 to 4360.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and including Period 2 data (since all patients met carry over criteria of Period 2 pre-dose AZ7550 concentration \>20% of Cmax).
Pharmacokinetics of AZ7550 (metabolite to AZD9291) by assessment of maximum plasma AZ7550 concentration
Outcome measures
| Measure |
AZD9291+Itraconazole
n=33 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=34 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
Cmax of AZ7550
|
1.897 nM
Interval 0.659 to 5.42
|
4.321 nM
Interval 1.64 to 11.7
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations, where AUC possible to calculate, and including Period 2 data (all patients met carry over criteria of Period 2 pre-dose AZ7550 concentration \>20% of Cmax).
Pharmacokinetics of AZ7550 (metabolite to AZD9291) by assessment of area under the plasma concentration time curve from zero to infinity
Outcome measures
| Measure |
AZD9291+Itraconazole
n=19 Participants
Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
|
AZD9291 Alone
n=33 Participants
Single oral dose of 80mg AZD9291 on Day 1
|
|---|---|---|
|
AUC of AZ7550
|
292.1 nM*h
Interval 158.0 to 578.0
|
624.1 nM*h
Interval 210.0 to 1700.0
|
Adverse Events
Overall
Serious events: 12 serious events
Other events: 39 other events
Deaths: 0 deaths
Part A
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Part B
Serious events: 9 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall
n=39 participants at risk
Parts A and B of the study combined.
|
Part A
n=39 participants at risk
In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods (AZD9291 dosing on Days 1 and 10). Patients additionally received itraconazole 200 mg twice daily dosing from Days 6 to 18.
|
Part B
n=38 participants at risk
In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastric ulcer
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/38 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Infections and infestations
Influenza
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/38 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Infections and infestations
Metapneumovirus infection
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/38 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Infections and infestations
Pneumonia
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/38 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Infections and infestations
Urinary tract infection
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Investigations
Hepatic enzyme increased
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/38 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/38 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/38 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
Other adverse events
| Measure |
Overall
n=39 participants at risk
Parts A and B of the study combined.
|
Part A
n=39 participants at risk
In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods (AZD9291 dosing on Days 1 and 10). Patients additionally received itraconazole 200 mg twice daily dosing from Days 6 to 18.
|
Part B
n=38 participants at risk
In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.4%
6/39 • Number of events 6 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
13.2%
5/38 • Number of events 5 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Ear and labyrinth disorders
Tinnitus
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
3/39 • Number of events 5 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.7%
3/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/38 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Gastrointestinal disorders
Constipation
|
20.5%
8/39 • Number of events 9 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
15.8%
6/38 • Number of events 7 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Gastrointestinal disorders
Diarrhoea
|
38.5%
15/39 • Number of events 17 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
34.2%
13/38 • Number of events 15 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Gastrointestinal disorders
Dry mouth
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Gastrointestinal disorders
Nausea
|
35.9%
14/39 • Number of events 18 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
17.9%
7/39 • Number of events 8 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
26.3%
10/38 • Number of events 10 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Gastrointestinal disorders
Oesophageal pain
|
5.1%
2/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Gastrointestinal disorders
Stomatitis
|
12.8%
5/39 • Number of events 5 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
13.2%
5/38 • Number of events 5 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Gastrointestinal disorders
Vomiting
|
25.6%
10/39 • Number of events 15 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
15.4%
6/39 • Number of events 8 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
15.8%
6/38 • Number of events 7 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
General disorders
Fatigue
|
30.8%
12/39 • Number of events 13 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
23.7%
9/38 • Number of events 10 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
General disorders
Influenza like illness
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
General disorders
Non-cardiac chest pain
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
General disorders
Oedema peripheral
|
10.3%
4/39 • Number of events 5 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Infections and infestations
Herpes zoster
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Infections and infestations
Paronychia
|
20.5%
8/39 • Number of events 9 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
21.1%
8/38 • Number of events 9 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Infections and infestations
Pneumonia
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Infections and infestations
Upper respiratory tract infection
|
12.8%
5/39 • Number of events 5 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Infections and infestations
Urinary tract infection
|
10.3%
4/39 • Number of events 5 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
4/39 • Number of events 8 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 8 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Investigations
Aspartate aminotransferase increased
|
10.3%
4/39 • Number of events 9 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 9 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
3/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Investigations
Blood creatine increased
|
5.1%
2/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Investigations
Electrocardiogram QT prolonged
|
7.7%
3/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Investigations
Neutrophil count decreased
|
5.1%
2/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.8%
12/39 • Number of events 12 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
28.9%
11/38 • Number of events 11 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.3%
4/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
4/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
4/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.3%
4/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Nervous system disorders
Dizziness
|
17.9%
7/39 • Number of events 9 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.3%
4/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 5 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Nervous system disorders
Headache
|
17.9%
7/39 • Number of events 9 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
15.8%
6/38 • Number of events 8 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Psychiatric disorders
Anxiety
|
10.3%
4/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Psychiatric disorders
Depressed mood
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Renal and urinary disorders
Dysuria
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
6/39 • Number of events 8 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 5 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.3%
4/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
10.3%
4/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
2/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.3%
4/39 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 4 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.8%
5/39 • Number of events 6 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
10.5%
4/38 • Number of events 5 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/38 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
0.00%
0/39 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
7.9%
3/38 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Vascular disorders
Deep vein thrombosis
|
5.1%
2/39 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/38 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
|
Vascular disorders
Hypertension
|
7.7%
3/39 • Number of events 3 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
2.6%
1/39 • Number of events 1 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
5.3%
2/38 • Number of events 2 • Approximately 3 weeks for Part A; up to approximately 15.5 months for Part B and approximately 16 months for Overall (Parts A and B combined).
Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 19), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
|
Additional Information
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