Trial Outcomes & Findings for Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer (NCT NCT00263588)
NCT ID: NCT00263588
Last Updated: 2019-12-12
Results Overview
Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population) Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer. The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS) A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
242 participants
Primary outcome timeframe
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Results posted on
2019-12-12
Participant Flow
The Intent-to-Treat (ITT) Population: all subjects who received at least one dose of study medication Modified ITT (MITT) Population: all subjects who received at least four doses (750 mg lapatinib twice daily for two days) of study medication and who had measurable brain metastases (≥1 cm in diameter) at baseline assessment
Main phase: ITT 95 in Cohort A, 147 in Cohort B. MITT, 94 in Cohort A, and 143 subjects in Cohort B Optional open-label extension phase: 51 subjects. Long-term follow up (LTFU) Protocol amendment added on 15-Apr-2013
Participant milestones
| Measure |
Cohort A
750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings
|
Cohort B
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
147
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
81
|
132
|
Reasons for withdrawal
| Measure |
Cohort A
750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings
|
Cohort B
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
|---|---|---|
|
Overall Study
Death
|
54
|
90
|
|
Overall Study
disease progression, coma, 1 unknown
|
10
|
11
|
|
Overall Study
Lost to Follow-up
|
7
|
10
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Investigator decision
|
7
|
15
|
|
Overall Study
Sponsor terminated study
|
0
|
1
|
Baseline Characteristics
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohorts A
n=95 Participants
Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings.
|
Cohort B
n=147 Participants
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 10.73 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
|
Age, Customized
<18 years · 242
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
18-64 years · 242
|
85 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Age, Customized
65-84 years · 242
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Customized
>85 years · 242
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South-East Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asia - East
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/ Caucasian/European
|
83 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: time from baseline to data cutoff (25 Sept 2007); approximately 2 yearsPopulation: Modified ITT (MITT) Population is defined as all subjects who received at least four doses (750 mg lapatinib 2x daily for 2 days) of study medication and who had measurable brain metastases (greater than or equal to 1cm in diameter) at baseline assessment. MITT was the primary population for analysis of efficacy data in lapatinib monotherapy arm.
Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population) Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer. The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS) A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms
Outcome measures
| Measure |
Cohort B
n=143 Participants
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
Cohorts A and B
n=94 Participants
Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily
|
|---|---|---|
|
The Number of Participants With Central Nervous System (CNS) Best Overall Response
Unknown
|
18 Participants
|
8 Participants
|
|
The Number of Participants With Central Nervous System (CNS) Best Overall Response
Complete response (CR)
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Central Nervous System (CNS) Best Overall Response
Partial response (PR)
|
9 Participants
|
6 Participants
|
|
The Number of Participants With Central Nervous System (CNS) Best Overall Response
Stable disease (SD)
|
46 Participants
|
40 Participants
|
|
The Number of Participants With Central Nervous System (CNS) Best Overall Response
Progressive disease (PD)
|
70 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: time from baseline to data cutoff (25 Sept 2007); approximately 2 yearsPopulation: Modified ITT (MITT) Population is defined as all subjects who received at least four doses (750 mg lapatinib 2x daily for 2 days) of study medication and who had measurable brain metastases (greater than or equal to 1cm in diameter) at baseline assessment. MITT was the primary population for analysis of efficacy data in lapatinib monotherapy arm.
Summary of CNS Objective Response (the Complete Response + Partial Response)
Outcome measures
| Measure |
Cohort B
n=143 Participants
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
Cohorts A and B
n=94 Participants
Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily
|
|---|---|---|
|
The Percentage of Participants With Central Nervous System (CNS) Objective Response Rate - Response Rate (CR + PR)
|
6 percentage of participants
Interval 2.9 to 11.6
|
6 percentage of participants
Interval 2.4 to 13.4
|
SECONDARY outcome
Timeframe: time from baseline to data cutoff (25 Sept 2007); approximately 2 yearsPopulation: MITT population Analysis was performed on combined cohorts in order to have a sufficient sample size to analyze association of CNS Volumetric Change from Baseline and NSS Improvement
Physician-reported NSS worksheet is derived from 13 AEs and measured by NCI CTCAE v3.0 grouped into 7 categories: level of consciousness, neurological symptoms, cranial nerves, language, strength, sensation, \& ataxia. Improvement of NSS required: Decrease by 1 or more grades from baseline of any tumor-related NSS, with confirmation at least 4 wks later, No development or worsening in any tumor-related NSS during interval, No radiographic evidence of CNS progression (assessed by volumetric MRI) or systemic (non-CNS) progression (assessed by RECIST) during interval, Stable or decreasing steroids during interval as defined by GSK equivalent doses of an alternative corticosteroid or a dose increase for non-tumor related reasons didn't constitute a steroid increase. Improvement in any non-tumor associated NSS didn't constitute improvement in NSS. Neurological exam, using Neurological Examination Worksheet was assessed at baseline \& each 4 wks. Categories below are not mutually exclusive.
Outcome measures
| Measure |
Cohort B
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
Cohorts A and B
n=237 Participants
Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily
|
|---|---|---|
|
Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet
Subjects with NSS improvement
|
—
|
24 Participants
|
|
Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet
>=20% volumetric reduction of lesion
|
—
|
8 Participants
|
|
Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet
any volumetric reduction of lesion
|
—
|
14 Participants
|
|
Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet
volumetric increase or withdrew
|
—
|
9 Participants
|
SECONDARY outcome
Timeframe: baseline and weeks 8, 16, 24, 32, 40, 48Population: MITT
Summary of Proportion of Subjects with a CNS Objective Response or Improvement in Baseline NSS
Outcome measures
| Measure |
Cohort B
n=143 Participants
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
Cohorts A and B
n=94 Participants
Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily
|
|---|---|---|
|
Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)
week 8
|
14 percentage of participants
Interval 7.8 to 21.5
|
23 percentage of participants
Interval 14.1 to 33.6
|
|
Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)
week 16
|
8 percentage of participants
Interval 2.2 to 19.2
|
2 percentage of participants
Interval 0.1 to 12.3
|
|
Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)
week 24
|
11 percentage of participants
Interval 1.3 to 33.1
|
8 percentage of participants
Interval 0.2 to 38.5
|
|
Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)
week 32
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
17 percentage of participants
Interval 0.4 to 64.1
|
|
Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)
week 40
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)
week 48
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: time from baseline to data cutoff (25 Sept 2007); approximately 2 yearsPopulation: Lapatinib monotherapy MITT
The duration of CNS objective response, defined as the time from first CNS Objective response until tumor progression at any site or death due to any cause. A CNS objective response was defined as either a Complete Response (CR) or Partial Response (PR), as assessed by volumetric analysis of magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of tumor-related neurological signs or symptoms.
Outcome measures
| Measure |
Cohort B
n=143 Participants
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
Cohorts A and B
n=94 Participants
Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily
|
|---|---|---|
|
Duration of Central Nervous System (CNS) Objective Response
|
1.58 months
Interval 0.99 to 3.55
|
2.43 months
Interval 0.99 to
Upper limit Not evaluable (Due to the low number of CNS responders, a meaningful interpretation of duration of response is not possible).
|
SECONDARY outcome
Timeframe: from Start of lapatinib to 6 monthsPopulation: MITT
The CNS disease control rate, defined as the percentage of subjects with CR, PR or stable disease at Week 24
Outcome measures
| Measure |
Cohort B
n=143 Participants
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
Cohorts A and B
n=94 Participants
Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily
|
|---|---|---|
|
Percentage of Patients With CNS Disease Control (Complete Response, Partial Response or Stable Disease) at 6 Months of Lapatinib Therapy
|
2 percentage of participants
Interval 0.4 to 6.0
|
9 percentage of participants
Interval 3.7 to 16.1
|
SECONDARY outcome
Timeframe: time from baseline to data cutoff (25 Sept 2007); approximately 2 yearsPopulation: Lapatinib Monotherapy MITT
Summary of Kaplan-Meier Estimates for Progression Free Survival at Any Site
Outcome measures
| Measure |
Cohort B
n=143 Participants
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
Cohorts A and B
n=94 Participants
Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily
|
|---|---|---|
|
Time to Progression (TTP) at Any Site
|
1.87 months
Interval 1.84 to 2.63
|
2.60 months
Interval 1.87 to 3.25
|
SECONDARY outcome
Timeframe: time from baseline to data cutoff (25 Sept 2007); approximately 2 yearsPopulation: Lapatinib Monotherapy MITT
Overall survival (OS) defined as the time from initiation of investigational product to death due to any cause.
Outcome measures
| Measure |
Cohort B
n=143 Participants
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
Cohorts A and B
n=94 Participants
Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily
|
|---|---|---|
|
Overall Survival (OS)
|
5.82 months
Interval 4.78 to 7.89
|
10.78 months
Interval 7.95 to 12.68
|
SECONDARY outcome
Timeframe: time from baseline to data cutoff (25 Sept 2007); approximately 2 yearsPopulation: MITT
baseline to time of disease progression or death
Outcome measures
| Measure |
Cohort B
n=143 Participants
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
Cohorts A and B
n=94 Participants
Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily
|
|---|---|---|
|
Summary of Site of First Progression
CNS progression
|
72 Participants
|
69 Participants
|
|
Summary of Site of First Progression
Non-CNS prgression
|
10 Participants
|
1 Participants
|
|
Summary of Site of First Progression
CNS and Non-CNS progression
|
36 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: time from baseline to data cutoff (25 Sept 2007); approximately 2 yearsPopulation: ITT
Summary of Overall All-cause mortality (Main Study and Extension)
Outcome measures
| Measure |
Cohort B
n=147 Participants
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.
|
Cohorts A and B
n=95 Participants
Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily
|
|---|---|---|
|
Primary Cause of Death
Other
|
4 Participants
|
4 Participants
|
|
Primary Cause of Death
Disease under study
|
124 Participants
|
74 Participants
|
Adverse Events
EGF105084/Cohort A
Serious events: 36 serious events
Other events: 90 other events
Deaths: 78 deaths
EGF105084/Cohort B
Serious events: 52 serious events
Other events: 131 other events
Deaths: 128 deaths
Serious adverse events
| Measure |
EGF105084/Cohort A
n=95 participants at risk
Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings
|
EGF105084/Cohort B
n=147 participants at risk
Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.3%
5/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
2.7%
4/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
1.4%
2/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Vascular disorders
Hypotension
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
On treatment deaths
|
21.1%
20/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
32.7%
48/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Diarrhoea
|
6.3%
6/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
2.7%
4/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
1.4%
2/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Haematemesis
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Nausea
|
3.2%
3/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
2.0%
3/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
3/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
3.4%
5/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Asthenia
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Complication associated with device
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Fatigue
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
General physical health deterioration
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Malaise
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Oedema
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Pain
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Performance status decreased
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Pyrexia
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Abscess limb
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Acinetobacter infection
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Cellulitis
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Erysipelas
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
2.0%
3/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Febrile infection
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Lung infection
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Necrotising fasciitis
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Oesophageal candidiasis
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Pneumonia
|
2.1%
2/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Sepsis
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Septic shock
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
2.7%
4/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Injury, poisoning and procedural complications
Head injury
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Investigations
Ejection fraction decreased
|
2.1%
2/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
2.7%
4/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
4/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
1.4%
2/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Aphasia
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Cognitive disorder
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Coma
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Dizziness
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Epilepsy
|
2.1%
2/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Headache
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Migraine
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Partial seizures
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Seizure
|
3.2%
3/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
3.4%
5/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Psychiatric disorders
Completed suicide
|
1.1%
1/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Psychiatric disorders
Depression
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Psychiatric disorders
Mental status changes
|
2.1%
2/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.00%
0/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
1.4%
2/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
Other adverse events
| Measure |
EGF105084/Cohort A
n=95 participants at risk
Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings
|
EGF105084/Cohort B
n=147 participants at risk
Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
5/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
4.8%
7/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
5/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
2.7%
4/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Constipation
|
9.5%
9/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
10.9%
16/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Diarrhoea
|
74.7%
71/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
62.6%
92/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Dry mouth
|
6.3%
6/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
4.1%
6/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
3/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
6.1%
9/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Nausea
|
30.5%
29/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
32.0%
47/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Gastrointestinal disorders
Vomiting
|
25.3%
24/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
26.5%
39/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Asthenia
|
9.5%
9/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
10.2%
15/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Fatigue
|
31.6%
30/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
19.7%
29/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Oedema peripheral
|
6.3%
6/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
10.9%
16/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
General disorders
Pyrexia
|
5.3%
5/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
4.1%
6/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
5/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
1.4%
2/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Infections and infestations
Urinary tract infection
|
7.4%
7/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
5.4%
8/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
4/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
8.8%
13/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Investigations
Blood bilirubin increased
|
7.4%
7/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
0.68%
1/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Investigations
Weight decreased
|
5.3%
5/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
7.5%
11/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.8%
16/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
19.0%
28/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
5/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
7.5%
11/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
5/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
4.8%
7/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
6/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
4.1%
6/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.1%
2/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
5.4%
8/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.4%
8/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
4.8%
7/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Dizziness
|
8.4%
8/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
3.4%
5/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Dysgeusia
|
5.3%
5/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
3.4%
5/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Nervous system disorders
Headache
|
25.3%
24/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
19.7%
29/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
5/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
5.4%
8/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.3%
6/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
7.5%
11/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.3%
6/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
7.5%
11/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.3%
6/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
6.8%
10/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.4%
7/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
10.2%
15/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.8%
16/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
14.3%
21/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.4%
8/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
8.8%
13/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.1%
40/95 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
25.2%
37/147 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months SAEs are presented from main and extension phase
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e.; data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER