Trial Outcomes & Findings for Evaluation of a New Vaccine Treatment for Patients With Metastatic Skin Cancer (NCT NCT01149343)
NCT ID: NCT01149343
Last Updated: 2020-11-20
Results Overview
The dose-limiting toxicities (DLT) were defined as follows: •An Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly ASCI related grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) persisting for 48 hours despite therapy. •An ASCI related or possibly ASCI related grade 2 or higher allergic reaction occurring within 24 hours following the ASCI administration. •An ASCI related or possibly ASCI related decrease in renal function, with a creatinine clearance lower than (\<) 40 milliliters per minute (mL/min). •An ASCI-related or possibly ASCI-related symptomatic and confirmed adrenal insufficiency. The grading used was defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 3 DLT = severe DLT. Related = DLT considered by investigator as possibly related to product administration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
107 participants
Primary outcome timeframe
During the study treatment (up to Year 4), for all patients
Results posted on
2020-11-20
Participant Flow
Participant milestones
| Measure |
GSK2302025A Cohort 1
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
24
|
22
|
40
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
24
|
22
|
40
|
Reasons for withdrawal
| Measure |
GSK2302025A Cohort 1
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
5
|
|
Overall Study
Death
|
10
|
13
|
18
|
18
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
|
Overall Study
Other
|
8
|
10
|
2
|
14
|
|
Overall Study
Sponsor study termination
|
0
|
0
|
0
|
2
|
|
Overall Study
Recurrence / Progressive disease
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Evaluation of a New Vaccine Treatment for Patients With Metastatic Skin Cancer
Baseline characteristics by cohort
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.3 Years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
60.8 Years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
59.5 Years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
60.7 Years
STANDARD_DEVIATION 18.1 • n=4 Participants
|
60.4 Years
STANDARD_DEVIATION 16.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · White - Caucasian / European Heritage
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Unspecified
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During the study treatment (up to Year 4), for all patientsPopulation: The analysis was performed on Phase 1 subjects from the Total treated population, which included all enrolled patients who have received at least one study dose injection.
The dose-limiting toxicities (DLT) were defined as follows: •An Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly ASCI related grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) persisting for 48 hours despite therapy. •An ASCI related or possibly ASCI related grade 2 or higher allergic reaction occurring within 24 hours following the ASCI administration. •An ASCI related or possibly ASCI related decrease in renal function, with a creatinine clearance lower than (\<) 40 milliliters per minute (mL/min). •An ASCI-related or possibly ASCI-related symptomatic and confirmed adrenal insufficiency. The grading used was defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 3 DLT = severe DLT. Related = DLT considered by investigator as possibly related to product administration.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Dose-limiting Toxicity (Phase I)
Patients with DLT
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Patients With Dose-limiting Toxicity (Phase I)
Patients with related DLT
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Patients With Dose-limiting Toxicity (Phase I)
Patients with severe DLT
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Patients With Dose-limiting Toxicity (Phase I)
Brain oedema
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Patients With Dose-limiting Toxicity (Phase I)
Microalbuminuria
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Patients With Dose-limiting Toxicity (Phase I)
Proteinuria
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: After the administration of dose 4, at Week 8Population: The analysis was performed on Phase 1 subjects with available results at Week 8, from the Total treated population, which included all enrolled patients who have received at least one study dose injection.
A seronegative/seropositive patient for anti-PRAME antibodies was a patient with antibody concentration lower (\<)/ higher than or equal to (≥) cut-off level. Humoral immune response was defined as a) if baseline concentration \< cut-off level: post treatment concentration ≥ cut-off level, or b) if baseline concentration ≥ cut-off level: post treatment concentration at least twice the baseline value. Cut-off values for seropositivity (by enzyme-linked immunosorbent assay \[ELISA\]) were 12 ELISA Units per milliliter (EL.U/mL).
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=13 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=13 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=17 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Percentage of Patients With Anti-PReferentially Expressed Antigen of MElanoma (Anti-PRAME) Humoral Immune Response (Phase I)
|
100 Percentage of patients
Interval 75.3 to 100.0
|
100 Percentage of patients
Interval 75.3 to 100.0
|
100 Percentage of patients
Interval 80.5 to 100.0
|
—
|
PRIMARY outcome
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administrationPopulation: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
The best overall response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). In general the patient's best response assignment depended on the achievement of both measurement and confirmation criteria. The best overall response includes the complete response (CR) defined as disappearance of all targeted/non-targeted lesions and partial response (PR) defined as at least 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD and persistence of one or more non-targeted lesion(s).
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Best Overall Response to Study Treatment (Phase II)
Patients with CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Best Overall Response to Study Treatment (Phase II)
Patients with PR
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administrationPopulation: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. The grading to be used by the investigators for the assessment of the severity of adverse events (AEs) was defined as the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life-threatening; Grade 5 = death related to AE). Adverse Events were coded to the preferred term (PT) level by means of the Medical Dictionary for Regulatory Activities (MedDRA).
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Any Unsolicited Adverse Events (AEs), by Maximum Grading
Grade 1
|
9 Participants
|
9 Participants
|
8 Participants
|
12 Participants
|
|
Number of Patients With Any Unsolicited Adverse Events (AEs), by Maximum Grading
Grade 2
|
6 Participants
|
6 Participants
|
10 Participants
|
15 Participants
|
|
Number of Patients With Any Unsolicited Adverse Events (AEs), by Maximum Grading
Grade 3
|
4 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
|
Number of Patients With Any Unsolicited Adverse Events (AEs), by Maximum Grading
Grade 4
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Any Unsolicited Adverse Events (AEs), by Maximum Grading
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administrationPopulation: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The grading to be used by the investigators for the assessment of the severity of adverse events (AEs) was defined as the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life-threatening; Grade 5 = death related to AE). SAEs were coded to the preferred term (PT) level by means of the Medical Dictionary for Regulatory Activities (MedDRA).
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Serious Adverse Events (SAEs), by Maximum Grading
Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Serious Adverse Events (SAEs), by Maximum Grading
Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Serious Adverse Events (SAEs), by Maximum Grading
Grade 3
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Serious Adverse Events (SAEs), by Maximum Grading
Grade 4
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Serious Adverse Events (SAEs), by Maximum Grading
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administrationPopulation: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged \[APTTP\], alanine aminotransferase increased \[ALT/I\], alkaline phoshatase increased \[APH/I\], anemia \[AN\], asparatate aminostransferase increased \[AST/I\], blood bilirubin increased \[BB/I\], creatinine increased \[CRE/I\], gamma glumatymtransferase increased \[GGT/I\], hemoglobin increased \[Hgb/I\], hypoalbuminemia \[HYP\], lymphocyte count decreased \[LYMC/D\], lymphocyte count increased \[LYMC/I\], neutrophil count decreased \[ NEUC/D\], platelet count decreased \[PLA/D\], white blood cell decreased \[WBC/D\]. Parameter grades (G0,1,2,3,4,Unknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 \[http://evs.nci.nih.gov/ftp1/CTCAE\]. This endpoint presents values for \[APTTP\] grading versus baseline parameter grading.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G0-GUnknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G1-GUnknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G2-GUnknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G3-GUnknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G4-GUnknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], GUknown-GUnknown
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G0-G0
|
13 Participants
|
16 Participants
|
18 Participants
|
33 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G1-G0
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G2-G0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G3-G0
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], GUnknown-G0
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G0-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G1-G1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G2-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], GUnknown-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G2-G2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G3-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], G4-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
[APTTP], GUknown-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administrationPopulation: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged \[APTTP\], alanine aminotransferase increased \[ALT/I\], alkaline phoshatase increased \[APH/I\], anemia \[AN\], asparatate aminostransferase increased \[AST/I\], blood bilirubin increased \[BB/I\], creatinine increased \[CRE/I\], gamma glumatymtransferase increased \[GGT/I\], hemoglobin increased \[Hgb/I\], hypoalbuminemia \[HYP\], lymphocyte count decreased \[LYMC/D\], lymphocyte count increased \[LYMC/I\], neutrophil count decreased \[ NEUC/D\], platelet count decreased \[PLA/D\], white blood cell decreased \[WBC/D\]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 \[http://evs.nci.nih.gov/ftp1/CTCAE\]. This endpoint presents values for \[ALT/I\] and \[APH/I\] grading versus baseline parameter grading.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], G0-G0
|
11 Participants
|
18 Participants
|
16 Participants
|
34 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], G1-G0
|
4 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], G2-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], GUknown-G0
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], G0-G1
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], G1-G1
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], G2-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[ALT/I], GUknown-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G0-G0
|
16 Participants
|
20 Participants
|
15 Participants
|
33 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G1-G0
|
1 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G2-G0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], GUknown-G0
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G0-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G1-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G2-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], GUknokwn-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G2-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G3-G2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], G4-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
[APH/I], GUknown-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administrationPopulation: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged \[APTTP\], alanine aminotransferase increased \[ALT/I\], alkaline phoshatase increased \[APH/I\], anemia \[AN\], asparatate aminostransferase increased \[AST/I\], blood bilirubin increased \[BB/I\], creatinine increased \[CRE/I\], gamma glumatymtransferase increased \[GGT/I\], hemoglobin increased \[Hgb/I\], hypoalbuminemia \[HYP\], lymphocyte count decreased \[LYMC/D\], lymphocyte count increased \[LYMC/I\], neutrophil count decreased \[ NEUC/D\], platelet count decreased \[PLA/D\], white blood cell decreased \[WBC/D\]. Parameter grades (G0,1,2,3,4,Uknown) were compared to baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 \[http://evs.nci.nih.gov/ftp1/CTCAE\]. This endpoint presents values for \[AN\], \[AST/I\] and \[CRE/I\] grading versus baseline parameter grading.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], G0-G0
|
12 Participants
|
10 Participants
|
10 Participants
|
21 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], G1-G0
|
1 Participants
|
6 Participants
|
5 Participants
|
12 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], G2-G0
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], G3-G0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], GUknown-G0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], G0-G1
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], G1-G1
|
2 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], G2-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], G3-G1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AN], GUnknown-G1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], G0-G0
|
13 Participants
|
18 Participants
|
17 Participants
|
36 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], G1-G0
|
3 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], G2-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], GUnknown-G0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], G0-G1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], G1-G1
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], G2-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[AST/I], GUnknown-G1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], G0-G0
|
16 Participants
|
21 Participants
|
19 Participants
|
38 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], G1-G0
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], G2-G0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], GUnknown-G0
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], G0-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], G1-G1
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], G2-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[BB/I], GUnknown-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administrationPopulation: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged \[APTTP\], alanine aminotransferase increased \[ALT/I\], alkaline phoshatase increased \[APH/I\], anemia \[AN\], asparatate aminostransferase increased \[AST/I\], blood bilirubin increased \[BB/I\], creatinine increased \[CRE/I\], gamma glumatymtransferase increased \[GGT/I\], hemoglobin increased \[Hgb/I\], hypoalbuminemia \[HYP\], lymphocyte count decreased \[LYMC/D\], lymphocyte count increased \[LYMC/I\], neutrophil count decreased \[ NEUC/D\], platelet count decreased \[PLA/D\], white blood cell decreased \[WBC/D\]. Parameter grades (G0,1,2,3,4,Uknown) were compared to baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 \[http://evs.nci.nih.gov/ftp1/CTCAE\]. This endpoint presents values for \[CRE/I\] and \[GGT/I\] grading versus baseline parameter grading.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G0-G0
|
20 Participants
|
22 Participants
|
20 Participants
|
33 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G1-G0
|
0 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G2-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], GUnknown-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G0-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G1-G1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G2-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], GUnknown-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G1-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G2-G2
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G3-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], G4-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[CRE/I], GUknown-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G0-G0
|
10 Participants
|
17 Participants
|
14 Participants
|
30 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G1-G0
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G2-G0
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], GUnknown-G0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G0-G1
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G1-G1
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G2-G1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G3-G1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], GUnknown-G1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G1-G2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G2-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G3-G2
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G4-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], GUnknown-G2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G2-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G3-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], G4-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[GGT/I], GUnknown-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administrationPopulation: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged \[APTTP\], alanine aminotransferase increased \[ALT/I\], alkaline phoshatase increased \[APH/I\], anemia \[AN\], asparatate aminostransferase increased \[AST/I\], blood bilirubin increased \[BB/I\], creatinine increased \[CRE/I\], gamma glumatymtransferase increased \[GGT/I\], hemoglobin increased \[Hgb/I\], hypoalbuminemia \[HYP\], lymphocyte count decreased \[LYMC/D\], lymphocyte count increased \[LYMC/I\], neutrophil count decreased \[ NEUC/D\], platelet count decreased \[PLA/D\], white blood cell decreased \[WBC/D\]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 \[http://evs.nci.nih.gov/ftp1/CTCAE\]. This endpoint presents values for \[Hgb/I\] and \[HYP\] grading versus baseline parameter grading.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G0-G0
|
16 Participants
|
24 Participants
|
21 Participants
|
37 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G2-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], GUnknown-G0
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G0-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G1-G1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G2-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], GUnknown-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G1-G2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G2-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G3-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], G4-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[Hgb/I], GUnknown-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G0-G0
|
13 Participants
|
17 Participants
|
18 Participants
|
30 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G1-G0
|
2 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G2-G0
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], GUnknown-G0
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G0-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G1-G1
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G2-G1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], GUnknown-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G2-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G3-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], G4-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
[HYP], GUnknown-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administrationPopulation: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged \[APTTP\], alanine aminotransferase increased \[ALT/I\], alkaline phoshatase increased \[APH/I\], anemia \[AN\], asparatate aminostransferase increased \[AST/I\], blood bilirubin increased \[BB/I\], creatinine increased \[CRE/I\], gamma glumatymtransferase increased \[GGT/I\], hemoglobin increased \[Hgb/I\], hypoalbuminemia \[HYP\], lymphocyte count decreased \[LYMC/D\], lymphocyte count increased \[LYMC/I\], neutrophil count decreased \[ NEUC/D\], platelet count decreased \[PLA/D\], white blood cell decreased \[WBC/D\]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 \[http://evs.nci.nih.gov/ftp1/CTCAE\]. This endpoint presents values for \[LYMC/D\] and \[LYMC/I\] grading versus baseline parameter grading.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G0-G0
|
10 Participants
|
14 Participants
|
14 Participants
|
28 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G1-G0
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G2-G0
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], GUnknown-G0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G0-G1
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G1-G1
|
3 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G2-G1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], GUnknown-G1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G0-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G1-G2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G2-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G3-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G4-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], GUnknown-G2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G0-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G1-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G2-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G3-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], G4-G3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/D], GUnknown-G3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/I], G0-G0
|
16 Participants
|
23 Participants
|
21 Participants
|
40 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/I], G1-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/I], G2-G0
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/I], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/I], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
[LYMC/I], GUnknown-G0
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administrationPopulation: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged \[APTTP\], alanine aminotransferase increased \[ALT/I\], alkaline phoshatase increased \[APH/I\], anemia \[AN\], asparatate aminostransferase increased \[AST/I\], blood bilirubin increased \[BB/I\], creatinine increased \[CRE/I\], gamma glumatymtransferase increased \[GGT/I\], hemoglobin increased \[Hgb/I\], hypoalbuminemia \[HYP\], lymphocyte count decreased \[LYMC/D\], lymphocyte count increased \[LYMC/I\], neutrophil count decreased \[NEUC/D\], platelet count decreased \[PLA/D\], white blood cell decreased \[WBC/D\]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 \[http://evs.nci.nih.gov/ftp1/CTCAE\]. This endpoint presents values for \[NEUC/D\], \[PLA/D\] and \[WBC/D\] grading versus baseline parameter grading.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], G0-G0
|
17 Participants
|
21 Participants
|
21 Participants
|
39 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], G1-G0
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], G2-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], GUnknown-G0
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], G0-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], G1-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], G2-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[NEUC/D], GUnknown-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], G0-G0
|
17 Participants
|
24 Participants
|
20 Participants
|
38 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], G1-G0
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], G2-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], GUnknown-G0
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], G0-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], G1-G1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], G2-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[PLA/D], GUnknown-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], G0-G0
|
14 Participants
|
21 Participants
|
19 Participants
|
34 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], G1-G0
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], G2-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], G3-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], G4-G0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], GUnknown-G0
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], G0-G1
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], G1-G1
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], G2-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], G3-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], G4-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
[WBC/D], GUnknown-G1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Data Lock Point at Week 8Population: The analysis was performed on the Phase 1 subjects with available results up to Week 8, from the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Cellular response was defined as: Geometric Mean Response (GMR) above the 2.68 cut-off value and at least a four-fold increase of PRAME- specific Cluster of Differentiation (CD) 4/8 T-cells. Considering that 2 studies failed to demonstrate clinical efficacy of recombinant protein based cancer vaccines, GSK decided in 2014 to stop the development and to stop recruitment in all the ongoing clinical studies. The decision was made to end the study (i.e., stopping patient enrollment, follow-ups, sample collection and analysis of samples for research purposes). Patients still on treatment at the time of the protocol amendment were offered to continue the administration of the study treatment until the last dose or until recurrence, whichever came first, or until the patient or the investigator decided to stop the study treatment. No further active protocol visit/contact was performed except for the concluding visit at Week 199, 30 days after the last treatment administration.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=8 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=11 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=14 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Percentage of Patients With Anti-PRAME Cellular (T-cell) Response (Phase I)
Patients with CD4 pre+post-administration results
|
100 Percentage of patients
Interval 63.1 to 100.0
|
100 Percentage of patients
Interval 71.5 to 100.0
|
100 Percentage of patients
Interval 76.8 to 100.0
|
—
|
|
Percentage of Patients With Anti-PRAME Cellular (T-cell) Response (Phase I)
Responders CD4
|
75.0 Percentage of patients
Interval 34.9 to 96.8
|
45.5 Percentage of patients
Interval 16.7 to 76.6
|
57.1 Percentage of patients
Interval 28.9 to 82.3
|
—
|
|
Percentage of Patients With Anti-PRAME Cellular (T-cell) Response (Phase I)
Patients with CD8 pre+post-administration results
|
100 Percentage of patients
Interval 63.1 to 100.0
|
100 Percentage of patients
Interval 66.4 to 100.0
|
100 Percentage of patients
Interval 63.1 to 100.0
|
—
|
|
Percentage of Patients With Anti-PRAME Cellular (T-cell) Response (Phase I)
Responders CD8
|
0.0 Percentage of patients
Interval 0.0 to 36.9
|
0.0 Percentage of patients
Interval 0.0 to 33.6
|
0.0 Percentage of patients
Interval 0.0 to 36.9
|
—
|
SECONDARY outcome
Timeframe: At Weeks 0, 4, 8, 10, 12, 29, 51, 75, 99, 123, 147 and conclusion visit at 30 days post last treatment administration (Week 199) for each patientPopulation: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
A seropositive patient was a patient whose anti-PRAME antibody concentration was greater than or equal to (≥) the assay cut-off value of 12 ELISA units per milliliter (EL.U/mL). A seronegative patient was defined as a patient whose pre-treatment antibody concentration was below (\<) the cut-off value. An anti-PRAME antibody responder was defined as: For a seronegative patient: a post-treatment antibody concentration ≥ the cut-off value; For a seropositive patient: a post-treatment antibody concentration ≥ twice the pre-treatment antibody concentration.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME,Week 0
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME, Week 4
|
11 Participants
|
14 Participants
|
18 Participants
|
33 Participants
|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME, Week 8
|
14 Participants
|
13 Participants
|
21 Participants
|
33 Participants
|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME, Week 10
|
10 Participants
|
12 Participants
|
19 Participants
|
33 Participants
|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME, Week 12
|
9 Participants
|
9 Participants
|
16 Participants
|
28 Participants
|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME, Week 29
|
2 Participants
|
4 Participants
|
5 Participants
|
13 Participants
|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME, Week 51
|
1 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME, Week 75
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME, Week 99
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME, Week 123
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME, Week 147
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
anti-PRAME, Week 199
|
6 Participants
|
12 Participants
|
8 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: At 30 days after the last treatment administration for each patient (Week 199)Population: The analysis was performed on the Total Vaccinated Cohort, which included all enrolled patients who have received at least one study dose injection.
Tumor response was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST), where stable disease for target lesions refers to neither enough shrinkage to qualify for complete response nor sufficient increase to qualify for progressive disease taking as references the smallest sum longest diameter (LD) since the treatment started. For non-targeted lesions it refers to persistence of one or more non-target lesions. Progressive disease is related to a clear increase of diameters of lesions taking as references the smallest diameters recorded since the treatment started OR the appearance of one or more new lesions OR both of these.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
Complete response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
Partial response
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
Stable disease
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
Stable Disease/Progressive disease
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
Progressive disease
|
9 Participants
|
18 Participants
|
15 Participants
|
31 Participants
|
|
Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
Non Evaluable
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
Missing Best overall response
|
7 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
Disease control: Yes
|
2 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
|
Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
Disease control: No
|
18 Participants
|
22 Participants
|
20 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: At 30 days after the last treatment administration for each patient (Week 199)Population: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Tumor response was assessed by the RECIST criteria, where SD for target lesions refers to neither enough shrinkage to qualify for CR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter (LD) since the treatment started. For non-targeted lesions it refers to persistence of one or more nom-target lesions. Progressive disease is related to a clear increase of diameters of lesions taking as references the smallest diameters recorded since the treatment started OR the appearance of one or more new lesions OR both of these. Mixed response is defined as at least 30% decrease in the LD occurring in at least one target lesion recorded and measured at baseline. Such response occurring in otherwise SD or PD status of the LD of target lesions were classified as "SD with target lesion regression" or "PD with target lesion regression", respectively. New lesion(s) in otherwise PR status of the LD of target lesions were "PR with new lesion".
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
PR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
MxR: SD with target lesion regression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
MxR: PD with target lesion regression
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
MxR: PR with new lesion
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
SD/PR
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
SD without mixed response
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
PD with SPD criteria
|
3 Participants
|
5 Participants
|
4 Participants
|
19 Participants
|
|
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
PD without SPD/MxR
|
4 Participants
|
12 Participants
|
8 Participants
|
9 Participants
|
|
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
Non Evaluable
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
Missing Best overall response
|
7 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Week 0, 4, 8, 12, 29, 51, 75, 99, 123, 147, 30 days after the last treatment administration for each patient (Week 199), with follow-up, 3, 6, 9 and 12 months after concluding visitPopulation: This analysis was not performed.
Analysis of immunogenicity for anti-PD antibodies was not performed, following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-PD antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 0, 4, 8, 12, 29, 51, 75, 99, 123, 147, 30 days after the last treatment administration for each patient (Week 199), with follow-up, 3, 6, 9 and 12 months after concluding visitPopulation: This analysis was not performed.
Analysis of immunogenicity for anti-CpG antibodies was not performed, following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-CpG antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to concluding visit, at Week 199Population: The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Time to treatment failure (TTF) was defined as the time from first administration of study product until the date of the last administration of the product, irrespective of the reason for study treatment discontinuation. Progression-free survival (PFS) was defined as the time from first adminsitration of study product until the date of either disease progression or death (for whatever reason), whichever comes first. Overall survival (OS) was defined as the time from first administration of study product until death.
Outcome measures
| Measure |
GSK2302025A Cohort 1
n=20 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 Participants
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 Participants
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Time to Treatment Failure, Progression Free Survival and Overall Survival (Phase I & II)
TTF
|
2.3 Months
Interval 1.0 to 4.9
|
2.3 Months
Interval 1.3 to 4.2
|
3.0 Months
Interval 2.3 to 4.9
|
4.6 Months
Interval 2.7 to 5.3
|
|
Time to Treatment Failure, Progression Free Survival and Overall Survival (Phase I & II)
PFS
|
2.7 Months
Interval 1.4 to 2.9
|
2.7 Months
Interval 1.0 to 2.8
|
2.8 Months
Interval 2.1 to 2.9
|
2.8 Months
Interval 2.7 to 3.3
|
|
Time to Treatment Failure, Progression Free Survival and Overall Survival (Phase I & II)
OS
|
17.0 Months
Interval 8.1 to
The upper limit of the 95% confidence interval for this group was below the limit of detection.
|
11.5 Months
Interval 7.3 to
The upper limit of the 95% confidence interval for this group was below the limit of detection.
|
10.8 Months
Interval 8.4 to 25.5
|
23.0 Months
Interval 15.5 to
The upper limit of the 95% confidence interval for this group was below the limit of detection.
|
SECONDARY outcome
Timeframe: Up to concluding visit, at Week 199Population: This analysis was not performed.
This analysis was not performed following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-CpG/anti-PD antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.
Outcome measures
Outcome data not reported
Adverse Events
GSK2302025A Cohort 1
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
GSK2302025A Cohort 2
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
GSK2302025A Cohort 3
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
GSK2302025A Cohort 4
Serious events: 5 serious events
Other events: 37 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
GSK2302025A Cohort 1
n=20 participants at risk
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 participants at risk
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 participants at risk
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 participants at risk
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Pain
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Erysipelas
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Infected skin ulcer
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Sciatica
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
Other adverse events
| Measure |
GSK2302025A Cohort 1
n=20 participants at risk
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 2
n=24 participants at risk
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 3
n=22 participants at risk
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
|
GSK2302025A Cohort 4
n=40 participants at risk
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
9.1%
2/22 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
7.5%
3/40 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
9.1%
2/22 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Administration site pain
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
12.5%
3/24 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Arteriosclerosis moenckeberg-type
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
8.3%
2/24 • Number of events 24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
15.0%
6/40 • Number of events 7 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Asthenia
|
10.0%
2/20 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
27.3%
6/22 • Number of events 21 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
32.5%
13/40 • Number of events 32 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Bacteriuria
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
2/20 • Number of events 5 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
7.5%
3/40 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Surgical and medical procedures
Catheter placement
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Chest discomfort
|
5.0%
1/20 • Number of events 6 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Chills
|
20.0%
4/20 • Number of events 10 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
18.2%
4/22 • Number of events 14 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
20.0%
8/40 • Number of events 14 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
9.1%
2/22 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
7.5%
3/40 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Cortisol decreased
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Cortisol increased
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
8.3%
2/24 • Number of events 6 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
10.0%
4/40 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
10.0%
4/40 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Cystitis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
2/20 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
8.3%
2/24 • Number of events 8 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
12.5%
5/40 • Number of events 7 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Psychiatric disorders
Dissociation
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
13.6%
3/22 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Fatigue
|
25.0%
5/20 • Number of events 10 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
29.2%
7/24 • Number of events 36 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
27.3%
6/22 • Number of events 10 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
17.5%
7/40 • Number of events 12 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Feeling cold
|
5.0%
1/20 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Haemoglobin decreased
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Headache
|
30.0%
6/20 • Number of events 12 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
20.8%
5/24 • Number of events 43 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
18.2%
4/22 • Number of events 9 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
17.5%
7/40 • Number of events 12 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Hot flush
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Hyperplasia
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
9.1%
2/22 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Hyperthermia
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Infection
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Inflammation
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Influenza
|
10.0%
2/20 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Influenza like illness
|
20.0%
4/20 • Number of events 18 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
25.0%
6/24 • Number of events 11 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
31.8%
7/22 • Number of events 16 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
32.5%
13/40 • Number of events 29 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Injection site erythema
|
15.0%
3/20 • Number of events 13 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
29.2%
7/24 • Number of events 17 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
31.8%
7/22 • Number of events 14 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
20.0%
8/40 • Number of events 18 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Injection site oedema
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
9.1%
2/22 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Injection site pain
|
45.0%
9/20 • Number of events 39 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
41.7%
10/24 • Number of events 32 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
54.5%
12/22 • Number of events 51 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
60.0%
24/40 • Number of events 90 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Injection site pruritus
|
10.0%
2/20 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 8 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Injection site reaction
|
25.0%
5/20 • Number of events 6 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
16.7%
4/24 • Number of events 8 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
9.1%
2/22 • Number of events 5 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Injection site swelling
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
9.1%
2/22 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Malaise
|
5.0%
1/20 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
9.1%
2/22 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
10.0%
4/40 • Number of events 6 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
4/20 • Number of events 5 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
8.3%
2/24 • Number of events 5 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
12.5%
5/40 • Number of events 5 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • Number of events 5 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
16.7%
4/24 • Number of events 8 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
9.1%
2/22 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
27.5%
11/40 • Number of events 14 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Neuralgia
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Oedema
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
9.1%
2/22 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Pain
|
15.0%
3/20 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
13.6%
3/22 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
20.0%
8/40 • Number of events 9 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
8.3%
2/24 • Number of events 13 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
9.1%
2/22 • Number of events 3 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
20.0%
8/40 • Number of events 9 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Peripheral coldness
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Pyrexia
|
30.0%
6/20 • Number of events 20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
33.3%
8/24 • Number of events 22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
22.7%
5/22 • Number of events 8 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
55.0%
22/40 • Number of events 86 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Rhinitis
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
10.0%
4/40 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Swelling
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 4 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Thrombophlebitis
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Tinea infection
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
16.7%
4/24 • Number of events 8 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
12.5%
5/40 • Number of events 5 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Bursitis
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Erysipelas
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Infected skin ulcer
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Sciatica
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.0%
1/20 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Antinuclear antibody increased
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Axillary pain
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Blood urea increased
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Body temperature increased
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Hypercholesterolaemia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Hypercreatinaemia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Hypoglycaemia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Hypokalaemia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Injection site discomfort
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Injection site inflammation
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Oedema peripheral
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
5.0%
2/40 • Number of events 2 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Skin infection
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Administration site induration
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Amnesia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Eosinophil count increased
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Injection site induration
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Periodontitis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Xerosis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
4.5%
1/22 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/40 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Blood glucose increased
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Feeling hot
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Gait disturbance
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Joint ankylosis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Laryngitis viral
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Investigations
Liver function test
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Localised infection
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Vascular disorders
Lymphostasis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Parosmia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
General disorders
Peripheral swelling
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Purpura senile
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Seizure
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/20 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/24 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
0.00%
0/22 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
2.5%
1/40 • Number of events 1 • Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER