Trial Outcomes & Findings for A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor (NCT NCT00796445)
NCT ID: NCT00796445
Last Updated: 2021-03-05
Results Overview
DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1351 participants
Primary outcome timeframe
At Final analysis (Month 30 = Year 2.5)
Results posted on
2021-03-05
Participant Flow
Out of 1351 patients enrolled in the study, 6 patients did not receive treatment and were excluded from study start, hence 1345 patients were included in the Total treated population-as treated (895 in the MAGE-A3 Group and 450 in the Placebo Group). Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the follow-up analysis, which included 1344 patients: 894 in the MAGE-A3 Group and 450 in the Placebo Group.
Participant milestones
| Measure |
MAGE-A3 Group
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|
|
Overall Study
STARTED
|
895
|
450
|
|
Overall Study
COMPLETED
|
310
|
158
|
|
Overall Study
NOT COMPLETED
|
585
|
292
|
Reasons for withdrawal
| Measure |
MAGE-A3 Group
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
5
|
3
|
|
Overall Study
Adverse event, serious fatal
|
10
|
5
|
|
Overall Study
Adverse event, non-fatal
|
4
|
0
|
|
Overall Study
Disease progression/recurrence
|
537
|
268
|
|
Overall Study
Other
|
10
|
7
|
|
Overall Study
Withdrawal by Subject
|
18
|
9
|
|
Overall Study
Invalid Informed Consent Form
|
1
|
0
|
Baseline Characteristics
A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor
Baseline characteristics by cohort
| Measure |
MAGE-A3 Group
n=895 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCIStudy products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=450 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
Total
n=1345 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 Years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
56.2 Years
STANDARD_DEVIATION 13.66 • n=7 Participants
|
56.1 Years
STANDARD_DEVIATION 13.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
345 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
533 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
550 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
812 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Japanese Heritage
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Arabic/North African Heritage
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian/European Heritage
|
880 Participants
n=5 Participants
|
443 Participants
n=7 Participants
|
1323 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Other - Mixed origin
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Final analysis (Month 30 = Year 2.5)Population: The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.
DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).
Outcome measures
| Measure |
MAGE-A3 Group
n=893 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=452 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
n=200 Participants
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
n=116 Participants
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
n=255 Participants
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
n=126 Participants
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Disease Free Survival (DFS)
|
0.505 First events per person-year
|
0.478 First events per person-year
|
0.500 First events per person-year
|
0.460 First events per person-year
|
0.437 First events per person-year
|
0.442 First events per person-year
|
PRIMARY outcome
Timeframe: At follow-up analysis (up to Year 5)Population: The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the follow-up analysis.
DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).
Outcome measures
| Measure |
MAGE-A3 Group
n=892 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=452 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
n=200 Participants
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
n=116 Participants
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
n=255 Participants
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
n=126 Participants
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Disease Free Survival (DFS)
|
0.366 First events per person-year
|
0.345 First events per person-year
|
0.345 First events per person-year
|
0.335 First events per person-year
|
0.316 First events per person-year
|
0.319 First events per person-year
|
SECONDARY outcome
Timeframe: At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)Population: The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the follow-up analysis.
Overall Survival (OS) was defined as the time to event from randomization to the date of death, irrespective of the cause of death. OS was expressed as the person-year rate i.e. the number of patients with death (n) over the sum of the follow-up periods in years (T). Patients alive at the time of the analysis were censored on the date last known to be alive.
Outcome measures
| Measure |
MAGE-A3 Group
n=893 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=452 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
n=200 Participants
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
n=116 Participants
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
n=255 Participants
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
n=126 Participants
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
OS, Final analysis
|
0.177 Events per person-year
|
0.165 Events per person-year
|
0.172 Events per person-year
|
0.188 Events per person-year
|
0.165 Events per person-year
|
0.151 Events per person-year
|
|
Overall Survival (OS)
OS, Follow-up analysis
|
0.146 Events per person-year
|
0.140 Events per person-year
|
0.146 Events per person-year
|
0.153 Events per person-year
|
0.132 Events per person-year
|
0.120 Events per person-year
|
SECONDARY outcome
Timeframe: At Final analysis (Month 30 = Year 2.5)Population: The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.
Disease Free Specific Survival (DFSS) was defined as the time to event from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. DFSS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment).
Outcome measures
| Measure |
MAGE-A3 Group
n=893 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=452 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
n=200 Participants
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
n=116 Participants
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
n=255 Participants
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
n=126 Participants
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Disease-free Specific Survival (DFSS)
|
0.499 First events per person-year
|
0.478 First events per person-year
|
0.500 First events per person-year
|
0.460 First events per person-year
|
0.434 First events per person-year
|
0.442 First events per person-year
|
SECONDARY outcome
Timeframe: At Final analysis (Month 30 = Year 2.5)Population: The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.
Distant Metastasis Free Survival (DMFS) was defined as the time to event from randomization to the date of first distant metastasis or date of death, whichever occurred first. DMFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of distant metastasis/death. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period).
Outcome measures
| Measure |
MAGE-A3 Group
n=893 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=452 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
n=200 Participants
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
n=116 Participants
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
n=255 Participants
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
n=126 Participants
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Distant Metastasis-free Survival (DMFS)
|
0.387 First events per person-year
|
0.342 First events per person-year
|
0.388 First events per person-year
|
0.337 First events per person-year
|
0.334 First events per person-year
|
0.307 First events per person-year
|
SECONDARY outcome
Timeframe: At Weeks 0, 6, 12 [on the day of and the day after treatment administration (TA)], at Month 6, 9, 12, 24, at the Concluding visit (Month 30) + 6 months and +12 Months and at disease recurrencePopulation: The analysis was performed on subjects with valid EQ-5D data from the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.
The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the Euro Quality of Life-5D (EQ-5D) questionnaire was available in their native language. The EQ-5D comprises a 5-dimensional descriptive system (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), where each item has 3 levels and together they define 243 possible health states. For each health state, a value (utility) was determined by using an additive algorithm. These utility scores were calculated for each patient at each timepoint at which an EQ-5D questionnaire was completed. The score had a maximum value of 1.0 corresponding to full health level, while lower scores, down to a minimum value of 0.0 reflected degradation in the health-related quality of life.
Outcome measures
| Measure |
MAGE-A3 Group
n=245 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=118 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Health-related Quality of Life
EQ-5D, Week 6 (day after TA)
|
0.722 Units on a scale
Standard Deviation 0.245
|
0.867 Units on a scale
Standard Deviation 0.174
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Week 12 (day of TA)
|
0.873 Units on a scale
Standard Deviation 0.158
|
0.887 Units on a scale
Standard Deviation 0.138
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Week 12 (day after TA)
|
0.788 Units on a scale
Standard Deviation 0.170
|
0.888 Units on a scale
Standard Deviation 0.126
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Month 6
|
0.879 Units on a scale
Standard Deviation 0.146
|
0.900 Units on a scale
Standard Deviation 0.156
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Month 9
|
0.891 Units on a scale
Standard Deviation 0.134
|
0.876 Units on a scale
Standard Deviation 0.194
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Month 12
|
0.891 Units on a scale
Standard Deviation 0.157
|
0.899 Units on a scale
Standard Deviation 0.149
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Month 24
|
0.894 Units on a scale
Standard Deviation 0.132
|
0.881 Units on a scale
Standard Deviation 0.150
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Month 30 + 6 months
|
0.727 Units on a scale
Standard Deviation 0.000
|
0.568 Units on a scale
Standard Deviation 0.074
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Month 30 + 12 months
|
0.791 Units on a scale
Standard Deviation 0.264
|
0.648 Units on a scale
Standard Deviation 0.344
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Disease recurrence
|
0.752 Units on a scale
Standard Deviation 0.261
|
0.815 Units on a scale
Standard Deviation 0.197
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Week 0 (day of TA)
|
0.842 Units on a scale
Standard Deviation 0.182
|
0.861 Units on a scale
Standard Deviation 0.159
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Week 0 (day after TA)
|
0.773 Units on a scale
Standard Deviation 0.182
|
0.873 Units on a scale
Standard Deviation 0.141
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life
EQ-5D, Week 6 (day of TA)
|
0.853 Units on a scale
Standard Deviation 0.183
|
0.865 Units on a scale
Standard Deviation 0.173
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 monthsPopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw.
The cut-off value was 27 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
MAGE-A3 Group
n=629 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=316 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
Anti-MAGE-A3, Week 0
|
25 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
Anti-MAGE-A3, Week 6
|
478 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
Anti-MAGE-A3, Week 12
|
424 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
Anti-MAGE-A3, Week 36
|
259 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
Anti-MAGE-A3, Week 48
|
224 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
Anti-MAGE-A3, Week 72
|
178 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
Anti-MAGE-A3, Week 120
|
257 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
Anti-MAGE-A3, Week 120+6 months
|
70 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 monthsPopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw.
Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in EL.U/mL.
Outcome measures
| Measure |
MAGE-A3 Group
n=629 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=316 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Anti-MAGE-A3, Week 0
|
11.0 EL.U/mL
Interval 10.6 to 11.4
|
11.4 EL.U/mL
Interval 10.7 to 12.1
|
—
|
—
|
—
|
—
|
|
Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Anti-MAGE-A3, Week 6
|
1451.6 EL.U/mL
Interval 1290.9 to 1632.3
|
11.9 EL.U/mL
Interval 11.0 to 12.9
|
—
|
—
|
—
|
—
|
|
Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Anti-MAGE-A3, Week 12
|
4031.6 EL.U/mL
Interval 3738.7 to 4347.4
|
11.3 EL.U/mL
Interval 10.6 to 12.1
|
—
|
—
|
—
|
—
|
|
Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Anti-MAGE-A3, Week 36
|
2189.6 EL.U/mL
Interval 2000.4 to 2396.7
|
11.4 EL.U/mL
Interval 10.4 to 12.4
|
—
|
—
|
—
|
—
|
|
Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Anti-MAGE-A3, Week 48
|
2243.4 EL.U/mL
Interval 2034.4 to 2473.8
|
11.3 EL.U/mL
Interval 10.2 to 12.6
|
—
|
—
|
—
|
—
|
|
Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Anti-MAGE-A3, Week 72
|
2489.4 EL.U/mL
Interval 2221.8 to 2789.4
|
11.2 EL.U/mL
Interval 10.0 to 12.5
|
—
|
—
|
—
|
—
|
|
Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Anti-MAGE-A3, Week 120
|
3109.7 EL.U/mL
Interval 2827.4 to 3420.2
|
12.7 EL.U/mL
Interval 10.9 to 14.8
|
—
|
—
|
—
|
—
|
|
Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Anti-MAGE-A3, Week 120+6 months
|
1293.4 EL.U/mL
Interval 1056.3 to 1583.7
|
10.8 EL.U/mL
Interval 9.9 to 11.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 monthsPopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw.
Treatment response defined as: - For initially seronegative patients: post-treatment antibody concentration ≥ 27 EL.U/mL; - For initially seropositive patients: post-treatment antibody concentration ≥ 2 fold the pre-treatment antibody concentration.
Outcome measures
| Measure |
MAGE-A3 Group
n=482 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=271 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, Week 6
|
476 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, Week 12
|
424 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, Week 36
|
259 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, Week 48
|
224 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, Week 72
|
178 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, Week 120
|
257 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Anti-MAGE-A3 Antibody Response
Anti-MAGE-A3, Week 120+6 months
|
70 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) post-treatment periodPopulation: The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.
Laboratory abnormalities belong to hematological and biochemical parameters such as: alanine aminotransferase \[ALT\], asparatate aminostransferase \[AST\], alkaline phoshatase \[AP\], bilirubin \[BIL\], creatinine \[CREA\], hemoglobin \[HGB\], leukocytes \[LEU\], lymphopenia \[LYMPH\], neutrophils \[NEU\], platelets \[PLA\]. Parameter grades (Grade \[G\] 0, 1, 2, 3, 4, Unknown) were compared to each baseline parameter grade (G Unknown, 0, 1, 2, 3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 of August 9, 2006.
Outcome measures
| Measure |
MAGE-A3 Group
n=894 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=450 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Unknown - G0
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Unknown - G1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Unknown - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Unknown - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Unknown - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Unknown - Unknown
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G0 - G0
|
625 Participants
|
337 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G0 - G1
|
98 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G0 - G2
|
10 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G0 - G3
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G0 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G0 - Unknown
|
36 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G1 - G0
|
45 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G1 - G1
|
49 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G1 - G2
|
14 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G1 - G3
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Unknown - G0
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Unknown - G1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Unknown - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Unknown - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Unknown - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Unknown - Unknown
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G0 - G0
|
701 Participants
|
356 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G0 - G1
|
88 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G0 - G2
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G0 - G3
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G0 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G0 - Unknown
|
40 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G1 - G0
|
24 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G1 - G1
|
18 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G1 - G2
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G1 - G3
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G1 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G1 - Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G2 - G0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G2 - G1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G0 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G0 - Unknown
|
38 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G1 - G0
|
18 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G1 - G1
|
14 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G1 - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G1 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G1 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G1 - Unknown
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Total - G0
|
776 Participants
|
397 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Total - G1
|
70 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Total - G2
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Total - G3
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Total - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Total - Unknown
|
42 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Unknown - G0
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Unknown - G1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Unknown - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Unknown - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Unknown - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Unknown - Unknown
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G0 - G0
|
771 Participants
|
383 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G0 - G1
|
33 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G0 - G2
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G0 - G3
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G0 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL,G 0 - Unknown
|
44 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G1 -G 0
|
11 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G1 - G1
|
10 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G1 -G 2
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G1 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G1 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G1 - Unknown
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G2 - G0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G2 - G1
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G2 - G2
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G2 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G2 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, G2 - Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Total - G0
|
789 Participants
|
391 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Total - G1
|
44 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G1 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G1 - Unknown
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G2 - G0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G2 - G1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G2 - G2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G2 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G2 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G2 - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Total - G0
|
799 Participants
|
398 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Total - G1
|
50 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Total - G2
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Total - G3
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Total - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Total - Unknown
|
41 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Unknown - G0
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Unknown - G1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Unknown - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Unknown - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Unknown - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Unknown - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Total - G2
|
16 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Total - G3
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Total - G4
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Total - Unknown
|
39 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Unknown - G0
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Unknown - G1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Unknown - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Unknown - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Unknown - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Unknown - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G0 - G0
|
762 Participants
|
382 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G0 - G1
|
53 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G0 - G2
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G0 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G0 - G4
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G0 - Unknown
|
39 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G1 - G0
|
13 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G1 - G1
|
15 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G1 - G2
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G1 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G1 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G1 - Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G2 - G0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G2 - G1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G2 - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G2 - G3
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G2 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, G2 - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Total - G0
|
777 Participants
|
391 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Total - G1
|
70 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Total - G2
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Total - G3
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Total - G4
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LEU, Total - Unknown
|
39 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Unknown - G0
|
8 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Unknown - G1
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Unknown - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Unknown - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Unknown - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Unknown - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G3 - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G3 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G3 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G3 - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Total - G0
|
671 Participants
|
314 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Total - G1
|
148 Participants
|
98 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Total - G2
|
23 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Total - G3
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Total - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, Total - Unknown
|
42 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Unknown - G0
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Unknown - G1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Unknown - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Unknown - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Unknown - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Unknown - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G0 - G0
|
781 Participants
|
393 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G0 - G1
|
39 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G0 - G2
|
9 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G0 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G0 - G4
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G0 - Unknown
|
43 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G1 - G0
|
7 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G1 - G1
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G1 - G2
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G1 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G1 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G1 - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G2 - G0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G2 - G1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G2 - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G2 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G2 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, G2 - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Total - G0
|
794 Participants
|
404 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Total - G1
|
46 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Total - G2
|
10 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Total - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Total - G4
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
NEU, Total - Unknown
|
43 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Total - G2
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Total - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Total - G4
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Total - Unknown
|
39 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G1 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G1 - Unknown
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G2 - G0
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G2 - G1
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G2 - G2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G2 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G2 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G2 - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G3 - G0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G3 - G1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G3 - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G3 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G3 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, G3 - Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Total - G0
|
674 Participants
|
362 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Total - G1
|
150 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Total - G2
|
25 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Total - G3
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Total - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
ALT, Total - Unknown
|
41 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G2 - G2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G2 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G2 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, G2 - Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Total - G0
|
728 Participants
|
374 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Total - G1
|
107 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Total - G2
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Total - G3
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Total - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AST, Total - Unknown
|
45 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Unknown - G0
|
9 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Unknown - G1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Unknown - G2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Unknown - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Unknown - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, Unknown - Unknown
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G0 - G0
|
749 Participants
|
378 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G0 - G1
|
56 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G0 - G2
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
AP, G0 - G3
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Total - G2
|
12 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Total - G3
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Total - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
BIL, Total - Unknown
|
49 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Unknown - G0
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Unknown - G1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Unknown - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Unknown - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Unknown - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, Unknown - Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G0 - G0
|
789 Participants
|
391 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G0 - G1
|
31 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G0 - G2
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G0 - G3
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G0 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G0 - Unknown
|
36 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G1 - G0
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G1 - G1
|
19 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G1 - G2
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
CREA, G1 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G0 - G0
|
636 Participants
|
326 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G0 - G1
|
78 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G0 - G2
|
7 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G0 - G3
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G0 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G0 - Unknown
|
35 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G1 - G0
|
39 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G1 - G1
|
77 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G1 - G2
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G1 - G3
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G1 - G4
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G1 - Unknown
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G2 - G0
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G2 - G1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G2 - G2
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G2 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G2 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, G2 - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Total - G0
|
678 Participants
|
355 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
HGB, Total - G1
|
157 Participants
|
69 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G0 - G0
|
633 Participants
|
303 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G0 - G1
|
93 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G0 - G2
|
17 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G0 - G3
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G0 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G0 - Unknown
|
38 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G1 - G0
|
29 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G1 - G1
|
49 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G1 - G2
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G1 - G3
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G1 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G1 - Unknown
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G2 - G0
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G2 - G1
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G2 - G2
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G2 - G3
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G2 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G2 - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G3 - G0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
LYMPH, G3 - G1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Unknown - G0
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Unknown - G1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Unknown - G2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Unknown - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Unknown - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Unknown - Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G0 - G0
|
796 Participants
|
390 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G0 - G1
|
34 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G0 - G2
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G0 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G0 - G4
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G0 - Unknown
|
36 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G1 - G0
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G1 - G1
|
15 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G1 - G2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G1 - G3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G1 - G4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, G1 - Unknown
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Total - G0
|
804 Participants
|
392 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Abnormal Haematological and Biochemical Parameters
PLA, Total - G1
|
49 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) follow-up period after treatmentPopulation: The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
MAGE-A3 Group
n=895 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=450 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Adverse Events (AEs)
|
822 Participants
|
333 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 up to study end (up to 5 years)Population: The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
MAGE-A3 Group
n=895 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=450 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs)
|
129 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 up to study end (up to 5 years)Population: The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
MAGE-A3 Group
n=895 Participants
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=450 Participants
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS+ Mage-A3 Sub-Group
Subset of patients with the pre-specified gene signature (GS+), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS+ Placebo Sub-Group
Subset of patients with the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
GS- Mage-A3 Sub-Group
Subset of patients without the pre-specified gene signature (GS-), receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
GS- Placebo Sub-Group
Subset of patients without the pre-specified gene signature, receiving placebo. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
|
33 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
MAGE-A3 Group
Serious events: 129 serious events
Other events: 819 other events
Deaths: 5 deaths
Placebo Group
Serious events: 64 serious events
Other events: 327 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MAGE-A3 Group
n=895 participants at risk
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=450 participants at risk
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Gastrointestinal disorders
Nausea
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Gastrointestinal disorders
Vomiting
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Chest pain
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Device dislocation
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Impaired healing
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Oedema peripheral
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Pyrexia
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.44%
2/450 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Angina pectoris
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Atrioventricular block
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Bradycardia
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Cardiac arrest
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Cardiac failure
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Cardiac failure acute
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Coronary artery disease
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Intracardiac thrombus
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Left ventricular failure
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Myocardial infarction
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Endocrine disorders
Basedow's disease
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Endocrine disorders
Lymphocytic hypophysitis
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Endocrine disorders
Polyglandular autoimmune syndrome type ii
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Eye disorders
Retinal vascular thrombosis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Eye disorders
Retinopathy
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Eye disorders
Vision blurred
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Gastrointestinal disorders
Diverticulum
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Gastrointestinal disorders
Ileal perforation
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Hepatobiliary disorders
Jaundice
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Abscess limb
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Appendicitis
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Cellulitis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
1.1%
5/450 • Number of events 5 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Cellulitis enterococcal
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Cystitis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Endocarditis bacterial
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Erysipelas
|
0.78%
7/895 • Number of events 9 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
1.1%
5/450 • Number of events 5 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
H1n1 influenza
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Localised infection
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Lung infection
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Lymph node abscess
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Lymphangitis
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Pharyngitis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Pilonidal cyst
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Pneumonia haemophilus
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Postoperative abscess
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Prostatitis escherichia coli
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Sepsis
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Streptococcal infection
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Urinary tract infection
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Urosepsis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Infections and infestations
Wound infection
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Investigations
Transaminases increased
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.8%
25/895 • Number of events 34 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
2.9%
13/450 • Number of events 14 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Focal nodular hyperplasia
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.0%
9/895 • Number of events 9 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.67%
3/450 • Number of events 3 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage i
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Porocarcinoma
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.67%
6/895 • Number of events 9 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.67%
3/450 • Number of events 3 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary tract neoplasm
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Nervous system disorders
Meningism
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Nervous system disorders
Multiple sclerosis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Nervous system disorders
Polyneuropathy
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Psychiatric disorders
Major depression
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Psychiatric disorders
Mental disorder
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Psychiatric disorders
Mental status changes
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Renal and urinary disorders
Bladder neck sclerosis
|
0.11%
1/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Renal and urinary disorders
Renal failure
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Renal and urinary disorders
Urinary retention
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.34%
3/895 • Number of events 3 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Skin and subcutaneous tissue disorders
Actinic elastosis
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Vascular disorders
Aortic aneurysm
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Vascular disorders
Deep vein thrombosis
|
0.22%
2/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Vascular disorders
Haematoma
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Vascular disorders
Hypertension
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Vascular disorders
Intermittent claudication
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Vascular disorders
Lymphocele
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Vascular disorders
Lymphoedema
|
0.11%
1/895 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.11%
1/895 • Number of events 2 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.00%
0/450 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/895 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.22%
1/450 • Number of events 1 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
Other adverse events
| Measure |
MAGE-A3 Group
n=895 participants at risk
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
|
Placebo Group
n=450 participants at risk
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
46/895 • Number of events 61 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
4.2%
19/450 • Number of events 26 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Gastrointestinal disorders
Nausea
|
13.7%
123/895 • Number of events 266 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
7.1%
32/450 • Number of events 43 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Asthenia
|
16.6%
149/895 • Number of events 354 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
10.2%
46/450 • Number of events 68 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Chills
|
20.0%
179/895 • Number of events 432 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
3.3%
15/450 • Number of events 23 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Fatigue
|
23.5%
210/895 • Number of events 490 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
14.0%
63/450 • Number of events 116 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Influenza like illness
|
29.2%
261/895 • Number of events 902 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
6.7%
30/450 • Number of events 46 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Injection site erythema
|
10.1%
90/895 • Number of events 241 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.67%
3/450 • Number of events 3 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Injection site oedema
|
5.4%
48/895 • Number of events 134 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
0.67%
3/450 • Number of events 5 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Injection site pain
|
36.3%
325/895 • Number of events 1057 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
4.9%
22/450 • Number of events 37 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Injection site reaction
|
17.9%
160/895 • Number of events 500 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
1.3%
6/450 • Number of events 9 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Pain
|
21.3%
191/895 • Number of events 480 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
4.2%
19/450 • Number of events 26 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
General disorders
Pyrexia
|
42.5%
380/895 • Number of events 1240 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
7.8%
35/450 • Number of events 44 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
84/895 • Number of events 165 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
6.9%
31/450 • Number of events 43 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.0%
188/895 • Number of events 456 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
5.1%
23/450 • Number of events 39 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.8%
115/895 • Number of events 207 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
5.8%
26/450 • Number of events 28 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Nervous system disorders
Headache
|
22.9%
205/895 • Number of events 550 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
12.2%
55/450 • Number of events 128 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
15.4%
138/895 • Number of events 297 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
2.2%
10/450 • Number of events 10 • Adverse events (AEs): Within the 31-day (Days 0-30) follow-up period after treatment. Serious Adverse Events: from Day 0 up to study end (up to 5 years).
|
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