Trial Outcomes & Findings for Gene Therapy Study in Severe Haemophilia A Patients (270-201) (NCT NCT02576795)
NCT ID: NCT02576795
Last Updated: 2025-04-10
Results Overview
Adverse events (AEs) with onset or worsening after the investigational product were included. Participants with more than one AE of the same category were counted only once for that category. Serious adverse event (SAE)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Approximately up to 7 years after dosing
Results posted on
2025-04-10
Participant Flow
This study was conducted at 5 sites in United Kingdom (Basingstoke, Cambridge, Birmingham, Royal London, London, \& Guy's and St. Thomas', London).
Total of 21 subjects were screened. Of those 21, 6 did not meet the eligibility criteria for enrollment in the study: 5 were found to be adeno-associated virus5 (AAV5) transduction inhibition (TI) or total antibody (TAb) positive, and 1 was assessed as being unable to comply with the requirements of the trial. Fifteen participants were enrolled in 270-201 and received BMN 270 in 1 of 4 dose cohorts
Participant milestones
| Measure |
BMN 270 6E12 vg/kg
Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 2E13 vg/kg
Cohort 2: 2E13 vg per kilogram, per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 4E13 vg/kg
Cohort 4: 4E13 vg per kilogram, per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 6E13 vg/kg
Cohort 3: 6E13 vg per kilogram, per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
6
|
7
|
|
Overall Study
COMPLETED
|
1
|
1
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
BMN 270 6E12 vg/kg
Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 2E13 vg/kg
Cohort 2: 2E13 vg per kilogram, per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 4E13 vg/kg
Cohort 4: 4E13 vg per kilogram, per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 6E13 vg/kg
Cohort 3: 6E13 vg per kilogram, per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Gene Therapy Study in Severe Haemophilia A Patients (270-201)
Baseline characteristics by cohort
| Measure |
BMN 270 6E12 vg/kg
n=1 Participants
Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 2E13 vg/kg
n=1 Participants
Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 4E13 vg/kg
n=6 Participants
Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 6E13 vg/kg
n=7 Participants
Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25.0 years
STANDARD_DEVIATION NA • n=5 Participants
|
43.0 years
STANDARD_DEVIATION NA • n=7 Participants
|
31.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 5.8 • n=4 Participants
|
31.3 years
STANDARD_DEVIATION 7.8 • n=21 Participants
|
|
Age, Customized
18 to < 40 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Customized
40 to < 60 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Baseline annualized FVIII usage
|
3486.66 IU/kg/year
STANDARD_DEVIATION NA • n=5 Participants
|
3022.48 IU/kg/year
STANDARD_DEVIATION NA • n=7 Participants
|
4704.16 IU/kg/year
STANDARD_DEVIATION 2345.75 • n=5 Participants
|
4444.48 IU/kg/year
STANDARD_DEVIATION 1969.50 • n=4 Participants
|
4389.70 IU/kg/year
STANDARD_DEVIATION 1965.51 • n=21 Participants
|
|
Baseline annualized number of FVIII infusions
|
87.35 infusions/year
STANDARD_DEVIATION NA • n=5 Participants
|
103.77 infusions/year
STANDARD_DEVIATION NA • n=7 Participants
|
142.83 infusions/year
STANDARD_DEVIATION 48.78 • n=5 Participants
|
120.12 infusions/year
STANDARD_DEVIATION 45.94 • n=4 Participants
|
125.93 infusions/year
STANDARD_DEVIATION 45.11 • n=21 Participants
|
|
Baseline ABR (treated bleeds)
|
2.00 bleeds/year
STANDARD_DEVIATION NA • n=5 Participants
|
3.00 bleeds/year
STANDARD_DEVIATION NA • n=7 Participants
|
12.17 bleeds/year
STANDARD_DEVIATION 15.35 • n=5 Participants
|
17.57 bleeds/year
STANDARD_DEVIATION 14.71 • n=4 Participants
|
13.40 bleeds/year
STANDARD_DEVIATION 14.26 • n=21 Participants
|
|
Baseline Bleed Counts (treated bleeds)
0 bleeds/year
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Baseline Bleed Counts (treated bleeds)
> 0 to 4
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Baseline Bleed Counts (treated bleeds)
> 4 to 10
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Baseline Bleed Counts (treated bleeds)
> 10
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
History of previous diseases
Hepatitis B(HepB)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
History of previous diseases
Hepatitis C(HepC)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
History of previous diseases
Human immunodeficiency virus(HIV)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
History of previous diseases
Liver disease(LD)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Number of target joints
0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Number of target joints
1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Number of target joints
2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Number of target joints
3
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Number of target joints
> 3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 7 years after dosingPopulation: Safety analysis Population: The Safety analysis population was defined as all enrolled participants who received any amount of study drug.
Adverse events (AEs) with onset or worsening after the investigational product were included. Participants with more than one AE of the same category were counted only once for that category. Serious adverse event (SAE)
Outcome measures
| Measure |
BMN 270 6E12 vg/kg
n=1 Participants
Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 2E13 vg/kg
n=1 Participants
Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 4E13 vg/kg
n=6 Participants
Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 6E13 vg/kg
n=7 Participants
Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
Participants with any AE
|
1 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Participants with any SAE
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Participants with any treatment-related AE
|
1 Participants
|
0 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Treatment-related SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Participants with any AE of Grade >= 3
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
AEs leading to dose adjustment during infusion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
AEs leading to dose interruption during infusion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
AEs leading to study drug discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Participants who died
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 13-16 post-BMN 270 infusionPopulation: Full Analysis Set (FAS) population: defined as all enrolled participants who receive study drug and have at least one Baseline and post-Baseline assessment.
Responder/Non responder status, where a responder was defined as a participant with median FVIII activity of \>= 5 IU/dL during Week 13-16 post-BMN 270 infusion
Outcome measures
| Measure |
BMN 270 6E12 vg/kg
n=1 Participants
Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 2E13 vg/kg
n=1 Participants
Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 4E13 vg/kg
n=6 Participants
Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 6E13 vg/kg
n=7 Participants
Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
|---|---|---|---|---|
|
Number of Participant With Median FVIII Activity Levels >= 5 IU/dL Using Chromogenic Substrate Assay (CSA)
|
0 Participants
|
0 Participants
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Week 13-16 post-BMN 270 infusionPopulation: FAS Population
Values for FVIII activity were excluded from analysis if obtained within 72 hours since the last infusion of exogenous FVIII replacement therapy FVIII activity levels below the Lower limit of quantitation (LLOQ) will be imputed with 0 IU/dL Q1: 25% Percentile; Q3: 75% Percentile
Outcome measures
| Measure |
BMN 270 6E12 vg/kg
n=1 Participants
Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 2E13 vg/kg
n=1 Participants
Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 4E13 vg/kg
n=6 Participants
Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 6E13 vg/kg
n=7 Participants
Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
|---|---|---|---|---|
|
Median FVIII Activity as Measured by Chromogenic Substrate Assay During Week 13-16 Post-BMN 270 Infusion
|
0.00 IU/dL
Interval 0.0 to 0.0
|
0.00 IU/dL
Interval 0.0 to 0.0
|
16.30 IU/dL
Interval 11.05 to 19.9
|
50.40 IU/dL
Interval 31.3 to 64.95
|
SECONDARY outcome
Timeframe: Week 5 and Beyond (Approximately 7 years post Infusion)Population: FAS Population
ABR= \[Number of bleeding episodes during calculation period\] / \[Total number of days during the calculation period\] ×365.25 A bleeding episode (treated) was defined as a bleed or symptoms associated with the development of a bleed (or multiple bleeds occurring in the same day) requiring FVIII replacement treatment within 72 hours of the start of the bleed. The baseline values for the secondary efficacy endpoints were based on the historical data prior to study enrollment. Annualized bleeding rate (ABR)
Outcome measures
| Measure |
BMN 270 6E12 vg/kg
n=1 Participants
Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 2E13 vg/kg
n=1 Participants
Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 4E13 vg/kg
n=6 Participants
Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 6E13 vg/kg
n=7 Participants
Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
|---|---|---|---|---|
|
Annualized Bleeding Rate Requiring Exogenous Factor VIII Replacement Treatment During Week 5 and Beyond
|
1.87 bleeds/year
Standard Deviation NA
Standard deviation could not be calculated for 1 participant
|
6.20 bleeds/year
Standard Deviation NA
Standard deviation could not be calculated for 1 participant
|
1.58 bleeds/year
Standard Deviation 1.97
|
0.75 bleeds/year
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Week 5 and Beyond (Approximately 7 years post Infusion)Population: FAS Population
Annualized FVIII use (IU/kg/yr.) =\[Sum of FVIII use (IU/kg) during calculation period\] / \[Total number of days during the calculation period\] ×365.25
Outcome measures
| Measure |
BMN 270 6E12 vg/kg
n=1 Participants
Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 2E13 vg/kg
n=1 Participants
Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 4E13 vg/kg
n=6 Participants
Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 6E13 vg/kg
n=7 Participants
Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
|---|---|---|---|---|
|
Annualized Factor VIII Utilization During Week 5 and Beyond
|
2536.47 IU/kg/yr
Standard Deviation NA
Standard deviation could not be calculated for 1 participant
|
279.27 IU/kg/yr
Standard Deviation NA
Standard deviation could not be calculated for 1 participant
|
331.65 IU/kg/yr
Standard Deviation 360.19
|
228.72 IU/kg/yr
Standard Deviation 311.68
|
SECONDARY outcome
Timeframe: Week 5 and Beyond (Approximately 7 years post Infusion)Population: FAS Population
Annualized FVIII infusion rate (count/yr.) = \[Number of FVIII replacement infusions during calculation period\] / \[Total number of days during the calculation period\] ×365.25
Outcome measures
| Measure |
BMN 270 6E12 vg/kg
n=1 Participants
Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 2E13 vg/kg
n=1 Participants
Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 4E13 vg/kg
n=6 Participants
Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 6E13 vg/kg
n=7 Participants
Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
|---|---|---|---|---|
|
Annualized Factor VIII Infusion Rate During Week 5 and Beyond
|
77.98 Infusions/ year
Standard Deviation NA
Standard deviation could not be calculated for 1 participant
|
10.09 Infusions/ year
Standard Deviation NA
Standard deviation could not be calculated for 1 participant
|
10.25 Infusions/ year
Standard Deviation 9.06
|
6.38 Infusions/ year
Standard Deviation 8.19
|
Adverse Events
BMN 270 6E12 vg/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
BMN 270 2E13 vg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BMN 270 4E13 vg/kg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
BMN 270 6E13 vg/kg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Overall
Serious events: 9 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BMN 270 6E12 vg/kg
n=1 participants at risk
Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 2E13 vg/kg
n=1 participants at risk
Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 4E13 vg/kg
n=6 participants at risk
Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 6E13 vg/kg
n=7 participants at risk
Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
Overall
n=15 participants at risk
Overall
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Haemophilic arthropathy
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acinic cell carcinoma of salivary gland
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Carotid artery dissection
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
Other adverse events
| Measure |
BMN 270 6E12 vg/kg
n=1 participants at risk
Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 2E13 vg/kg
n=1 participants at risk
Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 4E13 vg/kg
n=6 participants at risk
Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
BMN 270 6E13 vg/kg
n=7 participants at risk
Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV)
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
Overall
n=15 participants at risk
Overall
valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Eye disorders
Photophobia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Eye disorders
Scleral discolouration
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
57.1%
4/7 • Number of events 7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
40.0%
6/15 • Number of events 11 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
57.1%
4/7 • Number of events 7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
33.3%
5/15 • Number of events 8 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
General disorders
Chest discomfort
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
General disorders
Chest pain
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
33.3%
2/6 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
42.9%
3/7 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
40.0%
6/15 • Number of events 7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
General disorders
Hangover
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
33.3%
2/6 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
26.7%
4/15 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
General disorders
Pain
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
General disorders
Puncture site swelling
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
General disorders
Pyrexia
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
26.7%
4/15 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
General disorders
Swelling
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
General disorders
Vaccination site pain
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
33.3%
2/6 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
33.3%
2/6 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
26.7%
4/15 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Ear infection
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Epididymitis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Furuncle
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Hordeolum
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Influenza
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Nasopharyngitis
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
50.0%
3/6 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
71.4%
5/7 • Number of events 8 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
66.7%
10/15 • Number of events 16 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Rhinitis
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
26.7%
4/15 • Number of events 6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Tinea infection
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Upper respiratory tract infection
|
100.0%
1/1 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
33.3%
2/6 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
40.0%
6/15 • Number of events 8 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Viral infection
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
33.3%
2/6 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Procedural pain
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
83.3%
5/6 • Number of events 8 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
7/7 • Number of events 9 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
86.7%
13/15 • Number of events 19 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
83.3%
5/6 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
42.9%
3/7 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
60.0%
9/15 • Number of events 10 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
Blood alkaline phosphatase increased
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
Blood creatine phosphokinase increased
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
Blood lactate dehydrogenase increased
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
Blood urine present
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
C-reactive protein increased
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
Coagulation factor VIII level decreased
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
Coagulation factor VIII level increased
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
Gamma-glutamyltransferase increased
|
100.0%
1/1 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
Thrombin time prolonged
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Investigations
Weight increased
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
100.0%
1/1 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
83.3%
5/6 • Number of events 9 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
85.7%
6/7 • Number of events 16 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
86.7%
13/15 • Number of events 28 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
100.0%
1/1 • Number of events 6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
50.0%
3/6 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
46.7%
7/15 • Number of events 16 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
50.0%
3/6 • Number of events 6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
42.9%
3/7 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
40.0%
6/15 • Number of events 10 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Haemophilic arthropathy
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
71.4%
5/7 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
40.0%
6/15 • Number of events 8 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acinic cell carcinoma of salivary gland
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Aura
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Carotid artery dissection
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
50.0%
3/6 • Number of events 34 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
57.1%
4/7 • Number of events 10 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
53.3%
8/15 • Number of events 45 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Migraine
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 12 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 12 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Paraesthesia
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Parosmia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Sleep deficit
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Nervous system disorders
Typical aura without headache
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
42.9%
3/7 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
26.7%
4/15 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Renal and urinary disorders
Dysuria
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Renal and urinary disorders
Pollakiuria
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
33.3%
2/6 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
42.9%
3/7 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
40.0%
6/15 • Number of events 9 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
33.3%
2/6 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
26.7%
4/15 • Number of events 5 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Idiopathic guttate hypomelanosis
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Leukoderma
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
1/1 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/7 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 2 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
14.3%
1/7 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
6.7%
1/15 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Social circumstances
Pregnancy of partner
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
16.7%
1/6 • Number of events 1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
20.0%
3/15 • Number of events 4 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/1 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
0.00%
0/6 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
28.6%
2/7 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
13.3%
2/15 • Number of events 3 • Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT) AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
|
Additional Information
Konstantia-Maria Chavele, PhD, Director, Clinical Sciences
BioMarin (UK) Ltd
Phone: +44 207-4203351
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60