Trial Outcomes & Findings for Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer (NCT NCT02163733)
NCT ID: NCT02163733
Last Updated: 2024-01-22
Results Overview
Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 72 hours.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose in Part A.
Results posted on
2024-01-22
Participant Flow
First subject enrolled: 14 November 2014; Last Subject Last Visit for Part A: 23 March 2015 and Part B: 22 March 2016. The study was performed at 12 sites across Asia and Western Europe. Part A determined effect of food on PK of AZD9291; Part B allowed subjects further access to AZD9291 and provided additional safety data.
43 subjects were enrolled (signed informed consent). Subjects were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 5 subjects were enrolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment. The remaining 38 subjects started Period 1 and received treatment.
Participant milestones
| Measure |
Fed/Fasted
In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fed/Fasted treatment group followed Sequence 1: AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
|
Fasted/Fed
In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fasted/Fed treatment group followed Sequence 2: AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
|
AZD9291 Alone (Part B)
In Part B of the study, each patient (who completed Part A) received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
|
|---|---|---|---|
|
Part A: Day 1-9 (1st Intervention)
STARTED
|
18
|
20
|
0
|
|
Part A: Day 1-9 (1st Intervention)
COMPLETED
|
18
|
20
|
0
|
|
Part A: Day 1-9 (1st Intervention)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part A: Day 10-15 (2nd Intervention)
STARTED
|
18
|
20
|
0
|
|
Part A: Day 10-15 (2nd Intervention)
COMPLETED
|
18
|
20
|
0
|
|
Part A: Day 10-15 (2nd Intervention)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B: Day 15 to End Part B (AZD9291)
STARTED
|
0
|
0
|
38
|
|
Part B: Day 15 to End Part B (AZD9291)
COMPLETED
|
0
|
0
|
14
|
|
Part B: Day 15 to End Part B (AZD9291)
NOT COMPLETED
|
0
|
0
|
24
|
Reasons for withdrawal
| Measure |
Fed/Fasted
In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fed/Fasted treatment group followed Sequence 1: AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
|
Fasted/Fed
In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fasted/Fed treatment group followed Sequence 2: AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
|
AZD9291 Alone (Part B)
In Part B of the study, each patient (who completed Part A) received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.
|
|---|---|---|---|
|
Part B: Day 15 to End Part B (AZD9291)
Death
|
0
|
0
|
5
|
|
Part B: Day 15 to End Part B (AZD9291)
Disease progression
|
0
|
0
|
19
|
Baseline Characteristics
Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Fed/Fasted
n=18 Participants
In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fed/Fasted treatment group followed Sequence 1: AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
|
Fasted/Fed
n=20 Participants
In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fasted/Fed treatment group followed Sequence 2: AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 Years
STANDARD_DEVIATION 11.98 • n=99 Participants
|
61.4 Years
STANDARD_DEVIATION 11.00 • n=107 Participants
|
62.7 Years
STANDARD_DEVIATION 11.40 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 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 parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>5% of Cmax).
Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 72 hours.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=26 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=22 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
AUC(0-72) of AZD9291
|
7403 nM*h
Interval 3170.0 to 15600.0
|
7345 nM*h
Interval 3400.0 to 14700.0
|
PRIMARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.Population: All patients had at least 1 dose AZD9291 and had sufficient postdose PK to determine parameter without important protocol deviations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>5% of Cmax). Note 1 patient missing key 8 hour sample so not included in Cmax analysis.
Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=25 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=22 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
Cmax of AZD9291
|
199.6 nM
Interval 80.8 to 446.0
|
218.0 nM
Interval 95.2 to 381.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 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 parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>5% of Cmax).
Area under the plasma concentration curve from zero extrapolated to infinity.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=22 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=19 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
AUC of AZD9291
|
11640 nM*h
Interval 5460.0 to 24100.0
|
12530 nM*h
Interval 6050.0 to 25500.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 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 parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>5% of Cmax).
Area under the plasma concentration curve from time zero to last quantifiable dose.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=26 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=22 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
AUC(0-t) of AZD9291
|
10820 nM*h
Interval 4860.0 to 21800.0
|
10630 nM*h
Interval 5300.0 to 22600.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 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 parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>5% of Cmax).
Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=25 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=21 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
AUC(0-120) of AZD9291
|
9549 nM*h
Interval 4360.0 to 18800.0
|
9308 nM*h
Interval 4480.0 to 18900.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 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 parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>5% of Cmax).
Pharmacokinetics of AZD9291 by assessment of time to Cmax.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=25 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=22 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
Tmax of AZD9291
|
7.97 h
Interval 3.02 to 24.13
|
6.08 h
Interval 3.0 to 10.07
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 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 parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>5% of Cmax).
Pharmacokinetics of AZD9291 by assessment of the terminal half-life.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=25 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=21 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
t1/2 of AZD9291
|
52.82 h
Interval 32.1 to 84.4
|
54.64 h
Interval 31.2 to 84.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 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 parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>5% of Cmax).
Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=22 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=19 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
CL/F of AZD9291
|
13.75 L/h
Interval 6.65 to 29.3
|
12.78 L/h
Interval 6.28 to 26.5
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 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 parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \>5% of Cmax).
Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=22 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=19 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
Vz/F of AZD9291
|
1024 L
Interval 470.0 to 2580.0
|
1019 L
Interval 432.0 to 2200.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 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 parameter 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 for respective metabolite).
Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 72 hours.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=17 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=17 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
AUC(0-72) of AZ5104 and AZ7550
AZ5104
|
497.6 nM*h
Interval 138.0 to 1360.0
|
613.2 nM*h
Interval 270.0 to 1450.0
|
|
AUC(0-72) of AZ5104 and AZ7550
AZ7550
|
235.0 nM*h
Interval 82.7 to 1140.0
|
266.4 nM*h
Interval 112.0 to 590.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 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 parameter 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 for respective metabolite).
Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of maximum plasma concentration.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=17 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=17 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
Cmax of AZ5104 and AZ7550
AZ5104
|
9.163 nM
Interval 2.94 to 24.7
|
11.95 nM
Interval 4.95 to 28.6
|
|
Cmax of AZ5104 and AZ7550
AZ7550
|
4.236 nM
Interval 1.76 to 19.7
|
5.109 nM
Interval 1.78 to 11.3
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 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 parameter 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 for respective metabolite).
Area under the plasma concentration curve from time zero to last quantifiable dose for AZ5104 and AZ7550 (metabolites to AZD9291).
Outcome measures
| Measure |
Fed (High-fat Meal)
n=17 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=17 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
AUC(0-t) of AZ5104 and AZ7550
AZ5104
|
1033 nM*h
Interval 266.0 to 2590.0
|
1132 nM*h
Interval 535.0 to 2640.0
|
|
AUC(0-t) of AZ5104 and AZ7550
AZ7550
|
584.5 nM*h
Interval 178.0 to 2530.0
|
591.9 nM*h
Interval 270.0 to 1090.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 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 parameter 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 for respective metabolite).
Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 120 hours.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=16 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=17 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
AUC(0-120) of AZ5104 and AZ7550
AZ5104
|
744.4 nM*h
Interval 206.0 to 2050.0
|
875.7 nM*h
Interval 408.0 to 1940.0
|
|
AUC(0-120) of AZ5104 and AZ7550
AZ7550
|
373.4 nM*h
Interval 127.0 to 1820.0
|
411.4 nM*h
Interval 178.0 to 850.0
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 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 parameter 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 for respective metabolite).
Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of time to Cmax.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=17 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=17 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
Tmax of AZ5104 and AZ7550
AZ5104
|
24.17 h
Interval 8.08 to 72.75
|
8.03 h
Interval 4.0 to 49.03
|
|
Tmax of AZ5104 and AZ7550
AZ7550
|
24.60 h
Interval 8.08 to 120.58
|
10.00 h
Interval 6.0 to 73.53
|
SECONDARY outcome
Timeframe: Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 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 parameter 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 for respective metabolite).
Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of the terminal half-life.
Outcome measures
| Measure |
Fed (High-fat Meal)
n=17 Participants
AZD9291 tablets following a high-fat meal
|
Fasted
n=17 Participants
AZD9291 tablets following a period of fasting
|
|---|---|---|
|
t1/2 of AZ5104 and AZ7550
AZ5104
|
64.74 h
Interval 45.9 to 113.0
|
62.89 h
Interval 43.3 to 96.2
|
|
t1/2 of AZ5104 and AZ7550
AZ7550
|
85.26 h
Interval 52.2 to 142.0
|
91.54 h
Interval 58.2 to 204.0
|
Adverse Events
Overall Safety Population
Serious events: 8 serious events
Other events: 38 other events
Deaths: 2 deaths
Part A Safety Population
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Part B Safety Population
Serious events: 7 serious events
Other events: 37 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Overall Safety Population
n=38 participants at risk
Parts A and B of the study combined.
|
Part A Safety Population
n=38 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. Patients were randomised to either Sequence 1 (AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2) or Sequence 2 (AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2).
|
Part B Safety Population
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.
|
|---|---|---|---|
|
Cardiac disorders
ATRIAL FLUTTER
|
2.6%
1/38 • Number of events 1 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
LOWER RESPIRATORY TRACT INFECTION BACTERIAL
|
2.6%
1/38 • Number of events 1 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
NEUTROPENIC SEPSIS
|
2.6%
1/38 • Number of events 1 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 PNEUMOCOCCAL
|
2.6%
1/38 • Number of events 1 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
SEPSIS
|
2.6%
1/38 • Number of events 1 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
2.6%
1/38 • Number of events 1 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
2.6%
1/38 • Number of events 1 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
INTERVERTEBRAL DISC COMPRESSION
|
2.6%
1/38 • Number of events 1 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
2.6%
1/38 • Number of events 1 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
2.6%
1/38 • Number of events 1 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
RESPIRATORY DISTRESS
|
2.6%
1/38 • Number of events 1 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 Safety Population
n=38 participants at risk
Parts A and B of the study combined.
|
Part A Safety Population
n=38 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. Patients were randomised to either Sequence 1 (AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2) or Sequence 2 (AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2).
|
Part B Safety Population
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
|
15.8%
6/38 • Number of events 6 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
NEUTROPENIA
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
10.5%
4/38 • Number of events 4 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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).
|
|
Eye disorders
BLEPHARITIS
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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).
|
|
Eye disorders
CATARACT
|
7.9%
3/38 • Number of events 3 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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).
|
|
Eye disorders
DRY EYE
|
13.2%
5/38 • Number of events 5 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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).
|
|
Eye disorders
LACRIMATION INCREASED
|
7.9%
3/38 • Number of events 3 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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).
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
7.9%
3/38 • Number of events 3 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
10.5%
4/38 • Number of events 4 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
DENTAL CARIES
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
55.3%
21/38 • Number of events 45 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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).
|
50.0%
19/38 • Number of events 41 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
GASTRITIS
|
7.9%
3/38 • Number of events 3 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
GASTROOESOPHAGEAL REFLUX DISEASE
|
7.9%
3/38 • Number of events 3 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
26.3%
10/38 • Number of events 12 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 8 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
13.2%
5/38 • Number of events 5 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
15.8%
6/38 • Number of events 17 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 7 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 10 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
ASTHENIA
|
13.2%
5/38 • Number of events 7 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 6 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
23.7%
9/38 • Number of events 10 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
10.5%
4/38 • Number of events 5 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
PYREXIA
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
BRONCHITIS
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
CONJUNCTIVITIS
|
7.9%
3/38 • Number of events 4 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
GASTROENTERITIS
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
LOWER RESPIRATORY TRACT INFECTION
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
NASOPHARYNGITIS
|
5.3%
2/38 • Number of events 3 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
ORAL CANDIDIASIS
|
5.3%
2/38 • Number of events 3 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
26.3%
10/38 • Number of events 12 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 11 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
PHARYNGITIS
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
10.5%
4/38 • Number of events 5 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
5.3%
2/38 • Number of events 3 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
10.5%
4/38 • Number of events 6 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 6 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
10.5%
4/38 • Number of events 7 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 7 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 CREATININE INCREASED
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
WEIGHT DECREASED
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
26.3%
10/38 • Number of events 12 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 11 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
HYPOKALAEMIA
|
7.9%
3/38 • Number of events 4 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
13.2%
5/38 • Number of events 5 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
21.1%
8/38 • Number of events 8 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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).
|
18.4%
7/38 • Number of events 7 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
10.5%
4/38 • Number of events 4 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
MUSCULAR WEAKNESS
|
5.3%
2/38 • Number of events 3 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
15.8%
6/38 • Number of events 7 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 6 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
10.5%
4/38 • Number of events 4 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
BALANCE DISORDER
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
15.8%
6/38 • Number of events 11 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 7 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
PARAESTHESIA
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
SCIATICA
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
SOMNOLENCE
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
INSOMNIA
|
10.5%
4/38 • Number of events 4 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
POLLAKIURIA
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
15.8%
6/38 • Number of events 6 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 6 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
15.8%
6/38 • Number of events 7 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 6 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
EPISTAXIS
|
7.9%
3/38 • Number of events 4 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
15.8%
6/38 • Number of events 7 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
31.6%
12/38 • Number of events 12 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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).
|
31.6%
12/38 • Number of events 12 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
NAIL RIDGING
|
7.9%
3/38 • Number of events 3 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
7.9%
3/38 • Number of events 3 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 ERYTHEMATOUS
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
|
13.2%
5/38 • Number of events 5 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 MACULO-PAPULAR
|
10.5%
4/38 • Number of events 4 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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
HYPOTENSION
|
5.3%
2/38 • Number of events 2 • Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 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 15), 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).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator (PI) agrees to collaborate on the contents and formation of any publication and to pay due consideration to comments and opinions offered. AstraZeneca have 30 days for final manuscript review and may require that submission for publication be delayed in order to file patent application.
- Publication restrictions are in place
Restriction type: OTHER