Trial Outcomes & Findings for Phase I, Study in Chinese NSCLC Patients (NCT NCT02529995)
NCT ID: NCT02529995
Last Updated: 2020-02-11
Results Overview
Pharmacokinetics of AZD9291 after single dosing by assessment of maximum plasma AZD9291 concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.
Results posted on
2020-02-11
Participant Flow
All patients were enrolled in China: first patient enrolled on 24-08-2015. The recruitment was closed following LSI. The primary analysis for the PK was performed at the data cut off (DCO1): 28-01-2016. The study was on-going until the final analysis for the efficacy \& safety at the data cut off (DCO2): 02-11-2016 and the study is completed.
36 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 4 patients were enrolled but failed inclusion/exclusion criteria and 1 patient withdrew consent so were not eligible to be assigned treatment. The remaining 31 patients received treatment.
Participant milestones
| Measure |
AZD9291 40mg
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
Part A
STARTED
|
15
|
16
|
|
Part A
COMPLETED
|
0
|
0
|
|
Part A
NOT COMPLETED
|
15
|
16
|
|
Part B
STARTED
|
15
|
16
|
|
Part B
COMPLETED
|
9
|
4
|
|
Part B
NOT COMPLETED
|
6
|
12
|
Reasons for withdrawal
| Measure |
AZD9291 40mg
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
Part A
Ongoing Study at Data Cut-off
|
14
|
16
|
|
Part A
Discontinued Study
|
1
|
0
|
|
Part B
Ongoing Study at Data Cut-off
|
0
|
7
|
|
Part B
Discontinued Study
|
6
|
5
|
Baseline Characteristics
Phase I, Study in Chinese NSCLC Patients
Baseline characteristics by cohort
| Measure |
AZD9291 40mg
n=15 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=16 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 Years
STANDARD_DEVIATION 10.78 • n=5 Participants
|
60.1 Years
STANDARD_DEVIATION 10.92 • n=7 Participants
|
57.2 Years
STANDARD_DEVIATION 11.10 • n=5 Participants
|
|
Age, Customized
<50 Years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Customized
>=50-<65 Years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Customized
>=65-<75 Years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
>=75 Years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Chinese
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 after single dosing by assessment of maximum plasma AZD9291 concentration
Outcome measures
| Measure |
AZD9291 40mg
n=12 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=13 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
Cmax of AZD9291 After Single Dosing
|
103.8 nmol/L
Geometric Coefficient of Variation 79.21
|
195.9 nmol/L
Geometric Coefficient of Variation 49.83
|
PRIMARY outcome
Timeframe: PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 metabolites (AZ5104) after single dosing by assessment of maximum plasma concentration
Outcome measures
| Measure |
AZD9291 40mg
n=12 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=13 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
Cmax of AZ5104 After Single Dosing
|
4.207 nmol/L
Geometric Coefficient of Variation 79.85
|
9.582 nmol/L
Geometric Coefficient of Variation 71.63
|
PRIMARY outcome
Timeframe: PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 metabolites (AZ7550) after single dosing by assessment of maximum plasma concentration
Outcome measures
| Measure |
AZD9291 40mg
n=12 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=13 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
Cmax of AZ7550 After Single Dosing
|
3.443 nmol/L
Geometric Coefficient of Variation 68.42
|
7.842 nmol/L
Geometric Coefficient of Variation 50.62
|
PRIMARY outcome
Timeframe: PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 after single dosing by assessment of area under the plasma concentration time curve from zero to infinity
Outcome measures
| Measure |
AZD9291 40mg
n=11 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=13 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
AUC of AZD9291 After Single Dosing
|
6323 nmol*h/L
Geometric Coefficient of Variation 55.81
|
10260 nmol*h/L
Geometric Coefficient of Variation 33.10
|
PRIMARY outcome
Timeframe: PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 metabolites (AZ5104) after single dosing by assessment of area under the plasma concentration time curve from zero to infinity
Outcome measures
| Measure |
AZD9291 40mg
n=7 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=12 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
AUC of AZ5104 After Single Dosing
|
589.0 nmol*h/L
Geometric Coefficient of Variation 74.20
|
1077 nmol*h/L
Geometric Coefficient of Variation 57.22
|
PRIMARY outcome
Timeframe: PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 metabolites (AZ7550) after single dosing by assessment of area under the plasma concentration time curve from zero to infinity
Outcome measures
| Measure |
AZD9291 40mg
n=5 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=5 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
AUC of AZ7550 After Single Dosing
|
527.4 nmol*h/L
Geometric Coefficient of Variation 46.61
|
1292 nmol*h/L
Geometric Coefficient of Variation 29.31
|
PRIMARY outcome
Timeframe: PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Rate and extent of absorption of single dose AZD9291 by assessment of apparent clearance following oral administration
Outcome measures
| Measure |
AZD9291 40mg
n=11 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=13 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
CL/F of AZD9291 After Single Dosing
|
14.30 L/h
Standard Deviation 7.701
|
16.45 L/h
Standard Deviation 6.086
|
PRIMARY outcome
Timeframe: PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 after multiple dosing by assessment of maximum plasma concentration at steady state
Outcome measures
| Measure |
AZD9291 40mg
n=12 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=12 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
C(ss, Max) of AZD9291 After Multiple Dosing
|
303.4 nmol/L
Geometric Coefficient of Variation 47.96
|
550.4 nmol/L
Geometric Coefficient of Variation 32.35
|
PRIMARY outcome
Timeframe: PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 metabolites (AZ5104) after multiple dosing by assessment of maximum plasma concentration at steady state
Outcome measures
| Measure |
AZD9291 40mg
n=12 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=13 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
C(ss, Max) of AZ5104 After Multiple Dosing
|
29.43 nmol/L
Geometric Coefficient of Variation 46.66
|
49.98 nmol/L
Geometric Coefficient of Variation 39.73
|
PRIMARY outcome
Timeframe: PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 metabolites (AZ7550) after multiple dosing by assessment of maximum plasma concentration at steady state
Outcome measures
| Measure |
AZD9291 40mg
n=12 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=13 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
C(ss, Max) of AZ7550 After Multiple Dosing
|
25.91 nmol/L
Geometric Coefficient of Variation 51.72
|
54.15 nmol/L
Geometric Coefficient of Variation 31.34
|
PRIMARY outcome
Timeframe: PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval
Outcome measures
| Measure |
AZD9291 40mg
n=12 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=12 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
AUC(ss) of AZD9291 After Multiple Dosing
|
5698 nmol*h/L
Geometric Coefficient of Variation 52.59
|
9570 nmol*h/L
Geometric Coefficient of Variation 35.85
|
PRIMARY outcome
Timeframe: PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 metabolites (AZ5104) after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval
Outcome measures
| Measure |
AZD9291 40mg
n=12 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=13 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
AUC(ss) of AZ5104 After Multiple Dosing
|
561.5 nmol*h/L
Geometric Coefficient of Variation 51.74
|
964.7 nmol*h/L
Geometric Coefficient of Variation 37.03
|
PRIMARY outcome
Timeframe: PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 metabolites (AZ7550) after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval
Outcome measures
| Measure |
AZD9291 40mg
n=12 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=12 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
AUC(ss) of AZ7550 After Multiple Dosing
|
505.7 nmol*h/L
Geometric Coefficient of Variation 55.23
|
1123 nmol*h/L
Geometric Coefficient of Variation 29.05
|
PRIMARY outcome
Timeframe: PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.Population: Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.
Pharmacokinetics of AZD9291 after multiple dosing by assessment of apparent plasma clearance at steady state
Outcome measures
| Measure |
AZD9291 40mg
n=12 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=12 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
CL(ss)/F of AZD9291 After Multiple Dosing
|
15.74 L/h
Standard Deviation 8.532
|
17.67 L/h
Standard Deviation 6.072
|
SECONDARY outcome
Timeframe: Treatment discontinuation plus 28 days or 12 months after last subject first dose (LSFD). Results are based on data cut off of 2 Nov 2016.Population: All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
Outcome measures
| Measure |
AZD9291 40mg
n=15 Participants
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=16 Participants
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
Objective Response Rate (ORR)
|
46.7 % of participants
Interval 21.27 to 73.41
|
75.0 % of participants
Interval 47.62 to 92.73
|
Adverse Events
AZD9291 40mg
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
AZD9291 80mg
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD9291 40mg
n=15 participants at risk
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=16 participants at risk
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Cerebral artery embolism
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Coma
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Lethargy
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
Other adverse events
| Measure |
AZD9291 40mg
n=15 participants at risk
Single oral dose of AZD9291 40mg on Cycle 0 Day 1
|
AZD9291 80mg
n=16 participants at risk
Single oral dose of AZD9291 80mg on Cycle 0 Day 1
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Blood and lymphatic system disorders
Leukopenia
|
26.7%
4/15 • Number of events 10 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.3%
2/15 • Number of events 6 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Cardiac disorders
Angina pectoris
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Eye disorders
Cataract
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Eye disorders
Diplopia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Eye disorders
Dry eye
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Eye disorders
Eye swelling
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Eye disorders
Vision blurred
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Eye disorders
Visual acuity reduced
|
13.3%
2/15 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Eye disorders
Xerophthalmia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.3%
2/15 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
5/15 • Number of events 5 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
68.8%
11/16 • Number of events 19 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
3/15 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
25.0%
4/16 • Number of events 4 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Eructation
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
13.3%
2/15 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Haematochezia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.7%
1/15 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 4 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Oral mucosal exfoliation
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Stomatitis
|
13.3%
2/15 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
25.0%
4/16 • Number of events 14 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
6/15 • Number of events 9 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Fatigue
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Influenza like illness
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
18.8%
3/16 • Number of events 4 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Non-cardiac chest pain
|
13.3%
2/15 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
18.8%
3/16 • Number of events 5 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Peripheral swelling
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Pyrexia
|
20.0%
3/15 • Number of events 4 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Hepatobiliary disorders
Jaundice
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Herpes zoster
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Paronychia
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
37.5%
6/16 • Number of events 6 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
3/15 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Bilirubin conjugated increased
|
13.3%
2/15 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Blood bilirubin unconjugated increased
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Blood creatinine abnormal
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Blood urine present
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Electrocardiogram QT interval abnormal
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Haemoglobin decreased
|
6.7%
1/15 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Neutrophil count decreased
|
13.3%
2/15 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
31.2%
5/16 • Number of events 10 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Platelet count decreased
|
20.0%
3/15 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
25.0%
4/16 • Number of events 6 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
White blood cell count decreased
|
20.0%
3/15 • Number of events 5 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
37.5%
6/16 • Number of events 16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
3/15 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.3%
2/15 • Number of events 4 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Femoral hernia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Alanine aminotransferase increased
|
13.3%
2/15 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
25.0%
4/16 • Number of events 6 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
3/15 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Coma
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Dysstasia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
18.8%
3/16 • Number of events 4 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Lethargy
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Memory impairment
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Neuralgia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Post herpetic neuralgia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Tremor
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Psychiatric disorders
Soliloquy
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Renal and urinary disorders
Nocturia
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Renal and urinary disorders
Proteinuria
|
26.7%
4/15 • Number of events 7 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
18.8%
3/16 • Number of events 5 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
13.3%
2/15 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.7%
1/15 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
25.0%
4/16 • Number of events 5 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
5/15 • Number of events 5 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
5/15 • Number of events 5 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
25.0%
4/16 • Number of events 4 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
6.7%
1/15 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
18.8%
3/16 • Number of events 4 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
18.8%
3/16 • Number of events 3 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.7%
4/15 • Number of events 4 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.7%
1/15 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/16 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
12.5%
2/16 • Number of events 2 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
6.2%
1/16 • Number of events 1 • AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Systematic assessment due to regular investigator assessment at study visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60